[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)]
[Rules and Regulations]
[Pages 63578-63606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29906]




[[Page 63577]]

_______________________________________________________________________

Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 803, et al.



Medical Device User Facility and Manufacturer Reporting, Certification 
and Registration; Delegations of Authority; Medical Device Reporting 
Procedures; Final Rules

  Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / 
Rules and Regulations  
=======================================================================
-----------------------------------------------------------------------

[[Page 63578]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 807

[Docket No. 91N-0295]
RIN 0910-AA09


Medical Devices; Medical Device User Facility and Manufacturer 
Reporting, Certification and Registration

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; opportunity for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing regulations 
requiring medical device user facilities and manufacturers to report 
adverse events, related to medical devices, under a uniform reporting 
system. This regulation is mandated by the Safe Medical Devices Act of 
1990 (SMDA) and prescribes the conditions under which reports must be 
submitted, the content and timing of the requisite reports, and how FDA 
will utilize the information in carrying out its public health 
protection responsibilities. This rule is intended to augment the 
agency's postmarket surveillance activities and public health 
protection responsibilities relating to medical devices.
    In the future, FDA will propose to revoke the distributor adverse 
event reporting regulations that went into effect on May 28, 1992, by 
operation of law and replace them with provisions based on notice and 
comment. FDA will also propose to fully implement its authority under 
the Medical Device Amendments of 1992 (the 1992 amendments).

DATES: This final rule is effective April 11, 1996. Submit written 
comments, as requested elsewhere in this document by, January 10, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices 
and Radiological Health (HFZ-530), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.

SUPPLEMENTARY INFORMATION: On November 26, 1991 (56 FR 60024), FDA 
published a tentative final rule implementing the user and distributor 
reporting provisions of the SMDA (hereinafter referred to as the 
November 1991 tentative final rule). The agency received over 300 
comments in response to the tentative final rule, which are carefully 
evaluated and responded to in this final rule. The final rule also 
reflects the superseding reporting standard mandated by the Medical 
Device Amendments of 1992.

I. Highlights of the Final Rule

    This final rule provides FDA with increased post-market 
surveillance information by requiring medical device user facilities 
and manufacturers to report adverse event information as follows:
    (a) Medical device user facilities must submit a medical device 
report (MDR) to the device manufacturer within 10 days after becoming 
aware of a reportable death or serious injury (including serious 
illness). If the event involves a device-related death, or if the 
identity of the device manufacturer is not known, the report must be 
sent to FDA. User facilities must also submit a semiannual summary of 
reports to FDA.
    (b) Device manufacturers must submit MDR reports to FDA within 30 
days after becoming aware of a reportable death, serious injury, or 
malfunction.
    (c) Device manufacturers must annually certify the number of MDR 
reports filed with FDA during the preceding year.
    (d) Upon receiving information about an MDR reportable event, 
device manufacturers must submit a ``5-day report'' to FDA, within 5 
work days of: (1) Becoming aware that a reportable event or events, 
from any information, including any trend analysis, necessitates 
remedial action to prevent an unreasonable risk of substantial harm to 
the public health; or (2) becoming aware of an MDR reportable event 
from which FDA has made a written request for the submission of a 5-day 
report.
    (e) A device manufacturer is responsible for reporting MDR events 
related to its devices, whether or not the devices are still being 
marketed by the firm. If a manufacturer receives information about an 
event involving a device incorrectly identified as one marketed by that 
firm, the information received must still be forwarded to FDA, with an 
explanation that the device was misidentified.
    In finalizing this regulation, FDA has worked to meet the 
significant challenges of devising an effective medical device adverse 
event reporting system while balancing industry concerns with public 
health needs and statutory imperatives. The agency has also taken steps 
to minimize the administrative costs and paperwork burdens that will 
inevitably result for FDA, the medical device industry, and the device 
user community. FDA is keenly aware of and sensitive to the impacts of 
these new regulatory requirements on the pace of technological 
advancement and economic well-being of the medical device industry. At 
the same time, the agency is cognizant of the usefulness of information 
about the clinical performance of medical devices in fulfilling its 
public health mandate.
    In striving to achieve regulatory balance, the agency carefully 
analyzed over 300 public comments submitted in response to the November 
1991 tentative final rule, and resolved policy and legal issues arising 
from the comments and internal deliberations. This review of comments, 
combined with an economic threshold analysis, and other agency studies 
and deliberations, resulted in a number of major modifications that 
will facilitate compliance with the final reporting requirements and 
substantially reduce the overall costs, by an estimated $31 million, 
borne by device user facilities, the device industry, and the agency. 
These modifications are as follows:
    (a) The agency has eliminated certain criteria from the previously 
proposed manufacturer monthly reports including: An evaluation 
consisting of a narrative description of the results of statistical 
trend analyses conducted by the manufacturer, a discussion of the 
underlying methodologies used, a description of any unusual or 
unexpected events, and a description of any remedial actions taken.
    FDA believes that the benefits of the proposed mandatory trend 
analyses were not commensurate with the attendant costs to industry. 
Upon further review, the agency has determined that it would incur the 
costs of data entry regardless of the industry's analysis, and 
operating a computer program for the analysis of the data would be a 
relatively low cost to the agency. The proposed requirements for other 
information that the final regulation is not adopting will still be 
made available to the agency under the existing current good 
manufacturing practice (CGMP) regulations (21 CFR part 820), and under 
proposed 21 CFR part 806, reports of removals and corrections (59 FR 
13828, March 23, 1994).
    (b) The final regulation's reporting timeframe is shorter than the 
timeframe proposed. Earlier access to adverse event information will 
help the agency better to protect the public health.
    (c) The agency has eliminated the proposed training and educational 
requirements, which would have been particularly costly to user 
facilities, 

[[Page 63579]]
because the projected costs substantially exceeded expected benefits. 
This change will provide a net estimated annual cost saving of $29.1 
million.
    (d) The proposed imminent hazard report deadline has been extended 
from 3 days to 5 days, and renamed a 5-day report. This extended 
reporting timeframe should provide a more realistic opportunity for the 
manufacturer to conduct a preliminary investigation regarding the 
event. Any information not available for submission on the 5-day report 
must be submitted in a supplemental report.
    (e) The agency has developed reporting forms for baseline reports, 
semiannual reports, and annual certifications. This action will 
streamline the reporting procedure because industry will not be 
required to format its own reports. The standardized report forms and 
associated standardized electronic reporting formats will facilitate 
the input of information submitted into FDA's data base. This more 
efficient data processing will increase the agency's capacity to 
respond to critical device- related problems by permitting more rapid 
data analysis, leading to appropriate corrective measures.
    (f) The agency has adapted its MDR systems and reporting 
requirements in order to use the MEDWATCH form for reporting individual 
adverse events. In so doing, FDA has eliminated a number of proposed 
reporting elements, including the ``degree of certainty'' associated 
with a reportable event, the ``medical status of patients'' involved in 
device-related incidents, product ``service and maintenance,'' etc. The 
adoption of the MEDWATCH reporting form streamlines the reporting 
process and reduces the amount of information reporters must submit to 
FDA.
    (g) The agency has clarified that user facilities must report only 
information that is reasonably known to them, and are not required to 
investigate adverse events.
    (h) The agency has devoted much time and effort to accommodate 
electronic reporting. The agency is in the process of developing 
formats, guidelines, and procedures for electronic reports which, when 
available, will obviate the need for written agency approval for the 
use of electronic submissions.
    (i) In response to comments, the agency has clarified a number of 
the definitions included in the proposed rule and added new definitions 
to enhance clarity. The agency also substantially altered the 
organization and the paragraph designations of the final rule to 
provide information in the clearest and most usable form in part 803 
(21 CFR part 803).
    Revised part 803 has been subdivided into five subparts. Subpart A 
contains general provisions including sections for the scope, 
definitions, public availability of reports, and general reporting and 
record requirements.
    Subpart B of revised part 803 contains generally applicable 
reporting requirements for individual adverse event reports. Specific 
requirements for individual adverse event reports, and other reports 
required by user facilities and manufacturers, are in subparts C and E, 
respectively. Each subpart divides the reporting requirements for each 
type of reporting entity into separate sections that are organized to 
improve readability. The agency believes that the new organization of 
the regulation provides clearer guidance to industry than the 1991 
tentative final rule.

II. Background

    Under the Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C. 
301-394) (the act), and the Medical Device Amendments of 1976 (Pub. L. 
94-295) (the 1976 amendments), FDA issued medical device reporting 
regulations for manufacturers (49 FR 36326 at 36348, September 14, 
1984). To correct weaknesses noted in the 1976 amendments, and to 
better protect the public health by increasing reports of device-
related adverse events, Congress enacted the SMDA (Pub. L. 101-629), 
which required medical device user facilities, and distributors to 
report certain device-related adverse events. In response to a 
directive in the SMDA, FDA issued the November 1991 tentative final 
rule proposing to implement regulations concerning reporting of adverse 
events related to devices by user facilities and distributors. In the 
November 1991 tentative final rule, FDA also proposed to amend the 
existing manufacturer reporting regulations to conform to the proposed 
user facility and distributor reporting requirements.

A. User Facility, Manufacturer and Distributor Reporting Requirements 
Under the SMDA

    The SMDA added section 519(b)(1) to the act (21 U.S.C. 360i(b)(1)) 
to require that certain user facilities (hospitals, nursing homes, 
ambulatory surgical facilities and outpatient treatment facilities) 
report certain adverse events. The SMDA also authorized FDA to require 
diagnostic outpatient facilities to submit reports. Under the SMDA, 
user facilities must report device-related deaths to FDA and to the 
manufacturer. They must also report serious illnesses and injuries to 
the manufacturer, or to FDA if the manufacturer's identity is unknown. 
Reports must be made as soon as practicable, but no later than 10 
working days after the user facility becomes aware of a reportable 
event. In addition to individual adverse event reports, the SMDA 
requires each user facility to submit to FDA, on a semiannual basis, a 
summary of the reports it has submitted to FDA and to manufacturers. 
The provision in section 519(b) of the act that requires user 
facilities to report adverse events became effective by operation of 
law on November 28, 1991.
    In addition to requiring reporting by user facilities, the SMDA 
added section 519(a)(6) (subsequently redesignated as 519(a)(9) by the 
1992 amendments) to the act to require FDA to issue regulations 
regarding distributor reporting of adverse device events. The SMDA also 
added section 519(d) to the act to require both manufacturers and 
distributors to certify to FDA either the number of reports submitted 
in a year or that no such reports were submitted to the agency.
    Distributor reporting requirements became effective on May 28, 
1992, when the provisions relating to distributor reporting in the 
November 1991 tentative final rule became final by operation of law. In 
the Federal Register of September 1, 1993 (58 FR 46514), FDA published 
a notice announcing that the proposed distributor reporting regulations 
had become final by operation of law on May 28, 1992, and that these 
regulations had been amended by certain provisions of the 1992 
amendments discussed below.
    In the Federal Register of September 1, 1993, FDA also published a 
final rule, based on the November 1991 tentative final rule, requiring 
distributors to register and list their devices (58 FR 46514). 
Distributor registration and listing requirements became effective on 
October 1, 1993.
    In a future rulemaking, FDA will propose in the Federal Register to 
revoke the distributor regulation that went into effect by operation of 
law and replace it with provisions based on notice and comment.

B. User Facility, Manufacturer and Distributor Reporting Requirements 
Under the Medical Device Amendments of 1992

    Subsequent to FDA's issuance of the November 1991 tentative final 
rule to require adverse event reporting by user facilities, 
distributors, and manufacturers, on June 16, 1992, the President signed 
into law the 1992 

[[Page 63580]]
amendments (Pub. L. 102-300), amending certain provisions of section 
519 of the act relating to reporting of adverse device events. In the 
future, FDA will publish a proposed rule to fully implement its 
authority under the 1992 amendments. A summary of these changes 
follows:
1. Adoption of a Single Reporting Standard
    Section 5(a) of the 1992 amendments adopts a single standard to 
specify when injuries caused by devices must be reported to FDA. 
Manufacturers and importers are required to report a device-related 
adverse event to FDA whenever they receive or otherwise become aware of 
information that reasonably suggests that one of their marketed devices 
may have caused or contributed to a death or serious injury, or has 
malfunctioned and that such device or a similar device marketed by them 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur.
    Similarly, section 5(a) of the 1992 amendments revises the 
reporting requirements to require a user facility to report whenever 
the facility receives or otherwise becomes aware of information that 
reasonably suggests that a device ``has or may have caused or 
contributed'' to the death, serious illness or serious injury of a 
patient of the facility.
2. Single Definition of Types of Injuries That Must Be Reported
    Section 5(a) of the 1992 amendments also adopted a single 
definition for the types of injuries that user facilities, 
manufacturers, importers, and distributors must report. This definition 
requires reporting of an injury or illness that is: (1) Life-
threatening; (2) results in permanent impairment of a body function or 
permanent damage to a body structure; or (3) necessitates medical or 
surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. This definition 
differs from the previous statutory definition of ``serious injury'' or 
``serious illness'' in the user facility provisions and the definition 
in the November 1991 tentative final regulation. The new definition 
deleted the requirement that an injury must require immediate 
intervention to preclude permanent impairment or damage in order to 
qualify as a reportable adverse event.
3. New Authority To Require Reporting of ``Other Significant Adverse 
Device Experiences''
    The 1992 amendments also authorized FDA to issue regulations 
requiring user facilities, manufacturers, importers, and distributors 
to report ``significant adverse device experiences'' that the agency 
determines are necessary to be reported, other than deaths, serious 
injuries or serious illnesses, that might otherwise not fall within the 
definitions of reportable deaths, serious injuries, or malfunctions.

III. Reporting Forms

A. Individual Adverse Event Reports by User Facilities and 
Manufacturers

    Under Secs. 803.30 and 803.50, user facilities and manufacturers 
are required to submit device-related reports of individual adverse 
events on FDA Form 3500A or an FDA approved electronic equivalent. In 
order to simplify and consolidate reporting of adverse events, FDA 
announced in the Federal Register of February 26, 1993 (58 FR 11768) 
the availability of a new single ``MEDWATCH'' form for reporting 
adverse events and product problems with devices, drugs, biologics, 
special nutritional products and other products regulated by the agency 
(hereinafter referred to as the February 1993 notice). In response to 
FDA's request for comments on the form in the Federal Register, 79 
comments were submitted by medical device trade associations and other 
regulated or affected entities. On June 3, 1993 (58 FR 31596), after 
consideration of these comments, FDA published the final reporting 
form. (The form is described in Sec. 803.10.)

B. Annual Certification by Manufacturers

    Under Sec. 803.57, manufacturers must also submit at the time of 
their annual registration a completed FDA Form 3381 or an FDA approved 
electronic equivalent, certifying: (1) That all reportable events were 
submitted; (2) the number of reports submitted; or (3) that no reports 
were submitted during the previous 12-month period.

C. Semiannual Summaries by User Facilities

    Under Sec. 803.33, user facilities are required to submit, on FDA 
Form 3419 or an FDA approved electronic equivalent, a semiannual 
summary of all events reported during the prior reporting period. 
Semiannual reports must include information regarding the user 
facility, device manufacturers, products, and a brief description of 
the events.

D. Baseline Reports

    Under Sec. 803.55, manufacturers must submit baseline reports, on 
FDA Form 3417 or an FDA approved electronic equivalent, simultaneously 
with the submission of the first event report for each device. These 
reports, which are to be updated annually, must contain information on 
the manufacture and distribution of the relevant devices.

E. Effective Date of the Reports

    Adverse event reports and other related reports required by this 
regulation must be submitted using the appropriate forms or approved 
electronic equivalents, after April 11, 1996.

IV. Summary and Analysis of Comments and FDA's Response

    This final rule is based on FDA's analysis of the over 300 comments 
that the agency received in response to the November 1991 tentative 
final rule, and it conforms to certain statutory revisions in the 1992 
amendments. This final rule reflects actions in two areas. First, it 
revises the manufacturer reporting regulations that have been in effect 
since 1984. Second, it implements the statutorily directed user 
facility reporting requirements that have been in effect since November 
28, 1991.
    Originally, FDA gave interested persons until January 27, 1992, to 
comment on the November 1991 tentative final rule. In the Federal 
Register of January 24, 1992 (57 FR 2861), FDA extended the comment 
period until February 26, 1992. A summary of the comments and FDA's 
responses follow:

A. Section 803.1--Scope

    1. Several comments stated that the proposed regulation exceeds the 
SMDA and has no statutory authority. Many comments stated that the 
scope of the provisions was overly broad, and would increase the 
burdens, with unclear benefits, on all parties involved.
    The agency disagrees. Section 519 of the act, as amended by the 
SMDA and the 1992 amendments, provides clear authority to issue this 
regulation. Section 519 of the 1976 amendments granted FDA the 
authority to issue regulations to require manufacturers to maintain 
such records, make such reports, and provide such information to FDA as 
may reasonably be necessary to ensure that devices are not adulterated 
or misbranded and are otherwise safe and effective for human use. The 
legislative history of the 1976 

[[Page 63581]]
amendments reflects clear congressional intent to permit FDA to 
require, under the authority of section 519 of the act, manufacturers 
to report to FDA product defects and adverse effects of the firms' 
devices. (See H. Rept. 853, 94th Cong., 2d Sess. 23 (1976).)
    Among other things, section 519 of the act states that any 
reporting requirement established under the authority of that section: 
(1) May not be unduly burdensome (considering the cost of compliance 
and the need for the requirement); (2) shall state the purpose for any 
required report or information and identify to the fullest extent 
practicable such report or information; (3) may not, except in certain 
circumstances, require the disclosure of a patient's identity; and (4) 
may not, except in certain circumstances, require the manufacturer of a 
class I device to maintain records or to submit information not in its 
possession, unless such report or information is necessary to determine 
whether a device is misbranded or adulterated. The House Report 
cautions, however, that these limitations ``should not be construed as 
limiting the Secretary's authority to obtain information needed to 
insure that the public is protected from potentially hazardous 
devices.'' (Id.) In its discussion of section 519 of the act, the House 
Report lists examples of reasonable reporting requirements, including 
reports of defects, adverse reactions and patient injuries. It is also 
clear from the legislative history that Congress intended FDA to use 
its authority under section 519 of the act to protect the public from 
potentially hazardous devices, as well as from devices with confirmed 
hazards. (Id.)
    Since enactment of the 1976 amendments, Congress has focused 
considerable attention on FDA's implementation and enforcement of the 
act. Congress concluded that the 1976 amendments were not always 
adequate to protect the public health. (H. Rept. 808, 101st Cong., 2d 
Sess. 13-14 (1990); S. Rept. 513, 101st Cong., 2d Sess. 13-16 (1990).) 
To correct these problems, Congress passed and the President, on 
November 28, 1990, signed into law the SMDA, which amended the medical 
device provisions of the act.
    The SMDA added section 519(b)(1) to the act to require that certain 
user facilities (e.g., hospitals, nursing homes, ambulatory surgical 
facilities, and outpatient treatment facilities) report deaths related 
to medical devices to FDA, as well as to the manufacturer if the 
manufacturer's identity is known. Section 519(b)(5)(A) of the act also 
provides FDA with authority, which FDA has exercised in this final 
regulation, to include outpatient diagnostic facilities in this 
requirement. Serious illnesses and injuries are to be reported to the 
manufacturer, or to FDA if the manufacturer's identity is not known. 
Reports must be made as soon as practicable but no later than 10 
working days after the user facility becomes aware of an event. The 
responsibility for reporting is limited to events involving patients 
and employees of the facility. Each device user facility is also 
required to submit to FDA, on a semiannual basis, a summary of reports 
it has submitted to both FDA and manufacturers.
    Section 519(d) of the act, as added by the SMDA, also requires 
manufacturers to certify to FDA the number of reports submitted in the 
preceding 12-month period or, alternatively, certify that no such 
reports have been submitted to the agency during the same period. FDA 
believes that section 519 of the act, as amended by the SMDA and the 
1992 amendments, provides clear authority to issue this regulation for 
manufacturers and user facility reporting.
    Moreover, FDA does not believe that the provisions of this 
regulation are overly broad or unduly burdensome. FDA has reviewed and 
revised the regulation to clarify and limit the scope as appropriate. 
FDA believes that certain classes of persons, which might otherwise fit 
within the definition of manufacturer, should be exempt from the 
reporting requirements because reports from these persons are not 
necessary to ensure that the device is not adulterated or misbranded, 
and the device is otherwise safe and effective. Accordingly under 
Sec. 803.19, dental laboratories and optical laboratories have been 
exempted from the reporting requirements. FDA believes that these 
entities are not likely to receive reports of device-related deaths, 
serious injuries, or reportable malfunctions. In addition, requiring 
negative annual certification reports from these entities would be 
burdensome and not provide significant benefit to the public health. 
Therefore, FDA is excluding such entities from the reporting 
requirements. Other specific revisions are discussed in detail 
throughout this document.
    FDA believes this regulation carefully balances the interests of 
public health with industry burdens by limiting the required 
information to only that which is necessary to evaluate risks 
associated with medical devices and that it will enable the agency 
better to take appropriate regulatory measures to protect the public 
health. Furthermore, FDA does not believe that the burden on reporting 
entities will be significant. Based upon the number of reports FDA has 
received since the publication of the November 1991 tentative final 
rule, the agency anticipates that it will receive approximately 150,000 
reports the first year of this reporting program (the agency currently 
receives over 100,000 reports annually).
    2. Several comments pointed out that these provisions go beyond the 
scope of the SMDA in that the timeframes for reporting adverse events 
exceed the requirements of SMDA. Other comments argued that all 
employees of reporting entities should not be included under the 
reporting requirements of the SMDA, and that accordingly, the 
timeframes for reporting should not be triggered upon the knowledge of 
``any employee'' of a reporting entity.
    FDA does not agree that the regulation's 10-day reporting 
timeframes for user facilities and 5-day and 30-day reporting 
timeframes for manufacturers are beyond the scope of the SMDA. Section 
519(b)(1)(A) of the act specifies that user facilities must report 
certain adverse events as soon as practicable, but not later than 10 
work days after becoming aware of the information. This section further 
specifies that FDA has the discretion to prescribe, by regulation, a 
shorter reporting period. While the statute does not specify the time 
periods allowed to manufacturers, the timeframes are consistent with 
section 519 of the act, the legislative history and FDA's public health 
responsibility to require that the reports are forwarded to the agency 
in a timely manner. FDA believes the time periods prescribed in the 
final regulation allow sufficient time for reporting entities to gather 
information, and are sufficiently time sensitive to allow the agency to 
respond rapidly and appropriately to protect the public health.
    FDA also does not agree that employees of reporting entities should 
not be subject to the reporting requirements and that timeframes for 
reporting should not be triggered when employees of the reporting 
entities become aware of events. The scope of the act does not exclude 
any responsible persons who are employees of these entities from 
complying with section 519 of the act.
    Under the final regulation, the reporting periods are based upon 
the time at which the reporting entity becomes aware of the reportable 
event. FDA believes that the final regulation's definition of ``becomes 
aware'' in Sec. 803.3(c) properly defines the types of user facility 
and manufacturer employees who must become aware of a reportable event 
in order to trigger the reporting requirement. FDA believes 

[[Page 63582]]
that it will be feasible for user facilities and manufacturers to train 
the employees, described below, to be familiar enough with the 
obligation to report adverse events immediately to the appropriate 
person that the manufacturer or user facility designates as responsible 
for MDR reporting.
    Under Sec. 803.3(c), a device user facility is deemed to have 
``become aware'' when medical personnel of a facility become aware of a 
reportable event. ``Medical personnel'' are defined in Sec. 803.3(r) as 
individuals who are licensed, registered, or certified to administer 
health care; individuals with professional or scientific degrees; 
individuals who are responsible for receiving medical complaints or 
adverse event reports; or supervisors of such persons. FDA believes 
that a user facility can easily notify these types of employees about 
their obligation to immediately forward possible device-related adverse 
events to the appropriate person designated by the hospital to submit 
such reports.
    FDA believes that manufacturers have a direct responsibility to 
inform all employees to immediately forward adverse event information 
to the appropriate person appointed by those entities to submit MDR 
reports. Accordingly, FDA generally considers that a manufacturer 
becomes aware of an adverse event whenever any employee becomes aware 
of an adverse event. The one exception is for 5-day reports under 
Sec. 803.53(b), which requires manufacturers to submit a report when 
the manufacturer becomes aware of information that an adverse event or 
events necessitate remedial action to prevent an unreasonable risk of 
substantial harm to the public health.
    Under Sec. 803.53, manufacturers must submit a 5-day report under 
two different circumstances. The first type of 5-day reporting 
obligation arises after a manufacturer has received a written request 
from FDA for 5-day reports for specific types of adverse events. Under 
this circumstance, a 5-day report must be submitted when any employee 
becomes aware of an adverse event. FDA believes that the awareness of 
any employee should trigger the reporting requirement when FDA has 
informed the manufacturer of the need for specific adverse events that 
require 5-day reports because the manufacturer could easily inform all 
of its employees of FDA's request.
    The second type of 5-day report does not involve a direct request 
from FDA and is required only when the manufacturer becomes aware that 
an event or events necessitate remedial action to prevent an 
unreasonable risk of substantial harm to the public health. 
Accordingly, this type of 5-day reporting requirement would only arise 
if remedial action were required, and the remedial action is necessary 
to prevent an unreasonable risk of substantial harm to the public 
health. If no remedial action is required, or the remedial action is 
taken but it is not necessary to prevent an unreasonable risk to the 
public health, reportable adverse events should be submitted as 30 day 
reports.
    Because FDA does not believe certain employees, such as non-
technical staff, would be able to recognize that an adverse event or 
events may require remedial action to prevent a substantial risk to the 
public health, the final regulation requires that these types of 5-day 
reports be submitted only when employees holding certain positions of 
responsibility become aware of adverse event information. Accordingly, 
the final regulation considers a manufacturer to be aware of this type 
of 5-day report only when an employee with management or supervisory 
responsibilities over persons with regulatory, scientific, or technical 
responsibilities, or a person whose duties relate to the collection and 
reporting of adverse events, becomes aware that a reportable MDR event 
or events necessitate remedial action to prevent an unreasonable risk 
of substantial harm to the public health. FDA believes that limiting 
the type of person who must be aware of the adverse event to these 
types of individuals is appropriate because persons in these positions 
should be able to recognize that the event or events may present 
significant risks to the public health.
    3. Some comments suggested limiting the scope of these provisions 
so that reporting is required only when there is a death or serious 
injury. Other comments suggested that reports not be required if the 
device was only indirectly responsible for a death or serious injury, 
or was not a significant factor. Another comment suggested that 
reporting be limited to instances of malfunction.
    Section 519 of the act provides FDA with authority to require 
reporting of adverse events other than deaths or serious injuries. FDA 
has exercised this authority since 1984 by requiring manufacturers to 
report certain malfunctions. Moreover, section 519(a)(1) of the act (as 
amended by section 5 of the 1992 amendments) specifically states FDA's 
adverse event reporting regulations must require manufacturers to 
report malfunctions if the recurrence of the malfunction would be 
likely to cause a death or serious injury, regardless of whether an 
actual death or injury occurs. Because devices with such malfunctions 
pose significant risks, FDA needs to be informed of these incidents. 
The final regulation, therefore, requires manufacturers to report 
malfunctions when recurrence would be likely to cause a death or 
serious injury. User facilities are encouraged but not required to 
report malfunctions to manufacturers and distributors.
    Section 519(b)(1)(B)(ii) of the act, as added by the 1992 
amendments, also provides FDA with authority to require user 
facilities, distributors, and manufacturers to report other significant 
adverse device experiences that FDA determines necessary. Therefore, in 
a future issue of the Federal Register, FDA will propose to require 
that certain events be reported as significant adverse device 
experiences. Although some of these experiences may not have caused 
harm, FDA believes such events should be reported because of the 
potential risk to the public health if the event were to recur. Such 
information will enable the agency to take appropriate measures to 
prevent such recurrences.
    FDA also disagrees with the comments stating that reporting should 
be required only when a device directly causes an adverse event or is a 
significant factor. Section 519(a)(1) and (b)(1)(A) of the act requires 
reporting of any adverse event when information reasonably suggests 
that a marketed device ``may have caused or contributed'' to a 
reportable event (emphasis added). Limiting reporting to adverse events 
directly or significantly caused by devices would narrow the statutory 
reporting standard which requires reporting of adverse events when a 
device ``may have caused or contributed'' to an adverse event (emphasis 
added).
    FDA cannot agree with the comment that suggested reporting be 
limited to instances of malfunction. As stated above, section 519 of 
the act requires reporting of deaths and serious injuries, and 
authorizes FDA to require reporting of other significant adverse device 
experiences, as well as malfunctions.
    FDA does not agree with the comments that reporting should not be 
required when events are anticipated or intrinsically caused by the 
device. The statute does not exempt events that were anticipated or 
intrinsically caused by the device. (See section 519(a) (1) and 
(b)(1)(B) of the act.) Moreover, merely knowing that adverse events are 
anticipated or intrinsically caused by a device does not obviate the 
need for information contained in event reports. 

[[Page 63583]]
FDA needs to know the frequency and severity of adverse events in order 
to take appropriate action.
    4. One comment objected to providing warranty information. Other 
comments stated that a manufacturer's responsibility to report should 
end at the expiration of the warranty.
    The agency disagrees. Reporting requirements under section 519 of 
the act are not restricted or limited in any way by manufacturer 
warranties. Section 519 of the act requires manufacturers to report 
certain adverse events regardless of whether the warranty has expired. 
Warranties are private contracts between the purchaser and the 
manufacturer. In order to protect the public health and determine 
whether actions should be taken with respect to a device associated 
with an adverse event, FDA must receive information regarding all 
reportable events, including those that occur after a manufacturer's 
warranty has expired.
    5. One comment stated that certain adverse events may result from 
the user not knowing how to properly use the device, and that this 
would lead to the reporting of events properly attributable not to the 
device, but to its incorrect use.
    As with the 1984 manufacturer adverse event reporting regulation, 
this rule requires reports of certain adverse device events caused by 
user error. Device injuries attributed to user error may indicate that 
the device is misbranded within the meaning of section 502(f) of the 
act (21 U.S.C. 352(f)) in that the device fails to bear adequate 
directions for use or adequate warnings. In such cases, reports of 
adverse events that result from user error may alert FDA to the need 
for improved labeling to prevent future injuries.
    6. One comment suggested that independent device service personnel 
be added to the list of people required to report because some 
manufacturers may not receive reports from their own service personnel.
    Under section 519 of the act, only user facilities, manufacturers, 
and distributors are required to report adverse events to FDA. User 
facilities are considered to have ``become aware'' of such information 
whenever any medical personnel becomes aware of a reportable event. 
Manufacturers are considered to have ``become aware'' of events 
required to be reported in 30 days, or required to be reported in 5 
days, pursuant to an FDA request, when any employee becomes aware of an 
adverse event. Manufacturers are considered to have become aware of 
significant risk 5-day reports, which are more fully described in 
IV.A., comment 2, of this document, only when certain higher level 
employees become aware of adverse events requiring remedial action.
    FDA believes that an employee of a manufacturer includes 
independent service personnel who are contracted by manufacturers to 
service their medical devices. It is the responsibility of 
manufacturers to ensure that their service personnel, whether staff 
employees or under contract, are informed of the requirement to report 
deaths, serious injuries, malfunctions, or other significant adverse 
device experiences that may be required by regulation in the future.

B. Section 803.3--Definitions

    7. Many comments stated that the definition of ``device family'' 
(Sec. 803.3(e)) that is used to identify similar groups of devices on 
the manufacturer baseline report, is vague and overly broad. One 
comment suggested that each device be listed in the regulation; others 
suggested that the definition be deleted.
    FDA does not agree that the definition should be deleted. The 
identification of the device family on the baseline reports for 
individual device models will help FDA and manufacturers group similar 
models for analysis. This will aid in identifying the causation and 
nature of device-related problems. FDA agrees, however, that the 
definition should be clarified and has revised it accordingly. 
Manufacturers may use their own methods of grouping devices if the 
groupings meet the definition of ``device family,'' i.e., the devices 
have the same basic design and performance characteristics related to 
safety and effectiveness, intended use and function, and device 
classification and product code. FDA has the discretion to determine 
the appropriateness of a manufacturer's determination of the devices 
that comprise a device family. It would be impractical to list each 
device in the regulation.
    8. Many comments stated that the definition of ``device user 
facility'' (Sec. 803.3(f)) is vague. Several of these comments 
requested clarification regarding what facilities are included in the 
definition. Several comments suggested that certain groups (i.e., blood 
banks, independent rescue squads, school clinics or nurse offices, 
employee health units, dental offices and free-standing care units 
operating as private physician offices) be specifically included or 
excluded from the definition.
    FDA agrees in part. Under section 519(b)(5)(A) of the act, FDA has 
exercised its discretion to include outpatient diagnostic facilities 
that are not physician offices in the definition of ``device user 
facility.'' Under Sec. 803.3(f), device user facility means ``a 
hospital, ambulatory surgical facility, nursing home, or an outpatient 
diagnostic or treatment facility which is not a physician's office.'' 
To further clarify this definition, FDA has included definitions for 
the terms ``physician's office'' (Sec. 803.3(w)), ``hospital'' 
(Sec. 803.3(l)), ``ambulatory surgical facility,'' (Sec. 803.3(b)), 
``nursing home'' (Sec. 803.3(s)), ``outpatient diagnostic facility'' 
(Sec. 803.3(t)), and ``outpatient treatment facility'' (Sec. 803.3(u)).
    Under section 519(b)(5)(A) of the act, physicians' offices are 
excluded from the definition of user facilities and are thereby 
excluded from adverse event reporting requirements. FDA believes that 
groups performing functions similar to physicians' offices such as 
dental offices and offices of other health care practitioners (e.g., 
chiropractors, optometrists, nurse practitioners, school nurse offices, 
employee health clinics, free-standing care units) fall within the 
definition of ``physician's office'' and therefore should be excluded 
from reporting. FDA invites further public comment on the definition of 
``physician's office'' and may issue further guidance as necessary.
    FDA has defined ``outpatient treatment facility'' as a distinct 
entity that operates for the primary purpose of providing non-surgical 
therapeutic care. FDA believes that ambulance or rescue squad services 
and independent home health care agencies fall within this definition. 
Given the critical risks posed by potential malfunctions of devices 
used by ambulance services and in home health care settings, FDA 
believes the inclusion of these services within the definition of 
``outpatient treatment facility'' is appropriate.
    Blood banks that operate in hospitals or as outpatient treatment or 
outpatient diagnostic centers fall within the definition of user 
facility. Accordingly, device-related adverse events that meet the 
definition of MDR reportable event, as defined in Sec. 803.3(q), that 
occur in such blood banks must be reported. FDA invites further public 
comment on the definition of user facility and may issue further 
guidance as necessary.
    9. Several comments stated that the definition of ``imminent 
hazard'' relating to types of adverse events that FDA proposed should 
have 3-day reporting timeframes (proposed Sec. 803.3(g)) is unclear. A 
few comments suggested that the definition be deleted because it is too 
subjective, belongs in another regulation, or is beyond the scope of 
the SMDA. Some comments 

[[Page 63584]]
stated that more than 3 days were needed for reporting.
    FDA agrees. The agency is extending the time period to make such 
reports from 3 days to 5 days. FDA is also renaming ``imminent hazard 
reports'' as ``5-day reports'' (defined in Sec. 803.3(k)), and has 
clarified this requirement in Sec. 803.53.
    The purpose of the 5-day report is to alert the agency rapidly to 
adverse events that may pose an unreasonable risk of substantial harm 
to the public health. Thus, the definition of ``5-day report'' has been 
revised to mean a report of an adverse event required by a 
manufacturer, submitted on FDA Form 3500A or an FDA approved electronic 
equivalent within 5 work days of: (1) Any employee, who is a person 
with management or supervisory responsibilities over persons with 
regulatory, scientific, or technical responsibilities, or a person 
whose duties relate to the collection and reporting of adverse events, 
becoming aware that a reportable MDR event or events, from any 
information, including any trend analysis, necessitates remedial action 
to prevent an unreasonable risk of substantial harm to the public 
health; or (2) any employee becoming aware of an adverse event, if the 
manufacturer has received a written request from FDA for the submission 
of a 5-day report for those types of adverse events. When such a 
request is made, the manufacturer shall submit a 5-day report for all 
subsequent adverse events of the same nature that involve substantially 
similar devices for the time period specified in the written request. 
The time period stated in the original written request can be extended 
by FDA if it is in the interest of the public health.
    FDA does not intend that a manufacturer delay or interrupt a 
remedial action in order to submit a 5-day report. The report must be 
made within 5 days of the manufacturer becoming aware that a reportable 
event or events necessitate remedial action to prevent unreasonable 
risk of substantial harm to the public health. Information that would 
reasonably suggest remedial action is necessary to prevent such risk 
may, for example, be from one MDR reportable event that makes the 
manufacturer aware of a serious design flaw that necessitates remedial 
action to prevent an unreasonable risk of substantial harm to the 
public. On the other hand, information that would reasonably suggest 
remedial action is necessary may result from an internal trending 
analysis of several MDR reports that make the manufacturer aware that 
serious injuries or deaths occur at a much higher frequency than 
expected. Further discussion relating to when a manufacturer is 
considered aware of a reportable event is in section IV.A., comment 2, 
of this document.
    Manufacturers who submit 5-day reports are not required to submit 
reports of removals and corrections under section 519(f) of the act. 
Any information not available for reporting under the 5-day reporting 
timeframe may be submitted in a supplemental report.
    FDA does not agree with comments asserting that 5-day reports are 
beyond the scope of the SMDA or belong in another regulation. Requiring 
5-day reports is consistent with FDA's authority under section 
519(a)(1) of the act to issue regulations requiring manufacturers to 
report information that reasonably suggests that one of their marketed 
devices ``may have caused or contributed to a death or serious injury, 
or has malfunctioned and that such device * * * would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.'' For the protection of the public health, FDA may limit 
the time allowed to manufacturers for reporting events of which the 
agency should be quickly aware.
    10. Many comments stated that the requirements relating to user 
facility incident files (proposed Sec. 803.35(c)) that contain 
documents related to adverse events that a user facility must maintain 
are overly burdensome because the definition of ``incident files'' in 
proposed Sec. 803.3(h) is overly broad. Many of these comments 
suggested that the definition of incident files be removed or changed 
in order to clarify or limit the scope of requirements relating to the 
files. Other comments suggested that FDA's access to the files be 
limited.
    The agency agrees that the definition of these files (which have 
been renamed ``MDR event files'' in Sec. 803.18 of the final 
regulation) could be narrowed. Accordingly, FDA has revised the 
definition of MDR event files to include MDR reports filed with FDA or 
other entities, and documents related to the adverse event, including 
documents relating to deliberations and decisionmaking processes used 
in the evaluation or determination of whether an event is an MDR 
reportable event. The final rule also allows the reporter to 
incorporate certain information by reference, such as medical records, 
patient files, and engineering reports, rather than include them in the 
MDR event file.
    FDA does not agree that agency access to user facility files should 
be limited. Under Sec. 803.18(b), user facilities shall permit any 
authorized FDA employee during all reasonable times to have access to, 
and to copy and verify the records required under part 803. FDA has 
authority to inspect files under section 704(e) of the act (21 U.S.C. 
374(e)). Section 704(e) of the act states that every person required to 
maintain records under section 519 of the act, and every person who is 
in charge or custody of such records, shall permit FDA at all 
reasonable times to have access to and to copy and verify such records. 
In issuing a regulation stating its authority under section 704(e) of 
the act to have access to user facility adverse event files, FDA is 
exercising its duty under the statute to protect the public health by 
ensuring that user facilities comply with reporting requirements issued 
under section 519 of the act.
    11. Several comments stated that the definition of what kind of 
information triggers the reporting requirements, specifically, the 
definition of ``information that reasonably suggests that there is a 
probability that a device has caused or contributed to a death or 
serious injury, or serious illness'' (proposed Sec. 803.3(i)), is 
unclear and requires further definition.
    The agency agrees and has clarified this concept in Sec. 803.20(c). 
As explained in section II.B.1 of this document, section 5 of the 1992 
amendments revised section 519(a)(1) of the act, subsequent to FDA's 
November 1991 tentative final rule, to require the agency to issue 
regulations that require manufacturers and importers to report to FDA 
``whenever the manufacturer or importer receives or otherwise becomes 
aware of information that reasonably suggests that one of its marketed 
devices: (1) May have caused or contributed to a death or serious 
injury, or (2) has malfunctioned and that such device or a similar 
device marketed by the manufacturer or importer would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.'' Similarly, section 5 of the 1992 amendments revised 
the reporting standard for user facilities under section 519(b)(1) (A) 
and (B) of the act to require a user facility to submit a report 
whenever it receives or otherwise becomes aware of information ``that 
reasonably suggests that a device has or may have caused or contributed 
to a death * * * or serious illness of, or serious injury to, a patient 
of the facility * * *.''
    Under the revised 1992 amendments' statutory reporting standards, 
FDA has no discretion to change the reporting standards for 
manufacturers and user 

[[Page 63585]]
facilities. Accordingly, FDA has revised the wording of the reporting 
standards in the final regulation for user facilities and manufacturers 
to reflect the exact wording in the 1992 amendments for these entities. 
Therefore, the final regulation requires user facilities and 
manufacturers to report certain adverse events whenever there is 
``information that reasonably suggests that a device may have caused or 
contributed to a death or serious injury.''
    The final rule describes, in Sec. 803.20(c) ``[i]nformation that 
reasonably suggests that a device has or may have caused or contributed 
to an MDR reportable event'' to be any information, such as 
professional, scientific or medical facts and observations or opinions, 
that would reasonably suggest that a device has caused or may have 
caused or contributed to an MDR reportable event. Reports are not 
required when there is information that would cause a person who is 
qualified to make a medical judgment (e.g., a physician, risk manager, 
or biomedical engineer) to reach a reasonable conclusion that a device 
did not cause or contribute to an MDR reportable event. Information 
that leads to the conclusion that an event is not reportable must be 
retained in the MDR event files for the time periods specified in 
Sec. 803.18.
    The final rule further defines, in Sec. 803.3(d), ``caused or 
contributed'' to mean that a death or serious injury was or may have 
been attributable to a medical device, or that a medical device was or 
may have been a factor in the adverse event including events occurring 
as the result of its failure, malfunction, improper or inadequate 
design, labeling, performance, manufacture, or user error. Devices may 
cause or contribute to MDR reportable events either directly or 
indirectly.
    12. One comment stated that malfunctions of medical devices used 
for a nonmedical purpose should be exempted. Other comments stated that 
the term ``malfunction,'' as defined in Sec. 803.3(m), needed 
clarification, especially with regard to implanted devices. Another 
comment asked who is required to report implant malfunctions.
    Under this final regulation in subpart E of part 803 manufacturers 
must report certain malfunctions, including implant malfunctions, that 
would be likely to cause or contribute to an MDR reportable event, 
regardless of how the device is used. Although user facilities are not 
required by statute or regulation to report malfunctions, FDA 
encourages user facilities to report malfunction information to 
manufacturers and distributors. Malfunction reports provide important 
information to FDA concerning device safety.
    Reporters do not need to assess the likelihood that a malfunction 
will recur. The fact that the malfunction occurred once leads to the 
presumption that the malfunction will recur. A malfunction is 
reportable if any one of the following is true: (1) The chance of a 
death or serious injury occurring as a result of a recurrence of the 
malfunction is not remote; (2) the consequences of the malfunction 
affect the device in a catastrophic manner that may lead to a death or 
serious injury; (3) the malfunction results in the failure of the 
device to perform its essential function and compromises the device's 
therapeutic, monitoring or diagnostic effectiveness which could cause 
or contribute to a death or serious injury, or other significant 
adverse device experiences required by regulation (the essential 
function of a device refers, not only to the device's labeled use, but 
for any use widely prescribed within the practice of medicine); (4) the 
malfunction involves a long- term implant or a device that is 
considered to be life-supporting or life-sustaining and thus is 
essential to maintaining human life; or (5) the manufacturer takes or 
would be required to take an action under sections 518 or 519(f) of the 
act as a result of the malfunction of the device or other similar 
devices.
    Malfunctions are not reportable if they are not likely to result in 
a death, serious injury or other significant adverse device experience, 
that FDA, in a future rulemaking, may require by regulation. A 
malfunction which is or can be corrected during routine service or 
device maintenance must be reported if the recurrence of the 
malfunction would be likely to cause or contribute to a death or 
serious injury, or other significant adverse device experiences 
required by a future regulation.
    13. Several comments stated that the definition of a 
``manufacturer'' (Sec. 803.3(n)), who is subject to adverse event 
reporting requirements, is overly broad with regard to custom devices 
and devices modified by users. One comment suggested that the 
definition be modified to include manufacture for commercial 
distribution only.
    FDA believes that for protection of the public health, the 
definition should be broad enough to provide for reporting by all 
persons engaged in the manufacture, preparation, propagation, 
compounding, assembly or processing of medical devices, who may receive 
information about adverse events related to medical devices, except 
those manufacturers exempted under section 519(c) of the act and 
Sec. 803.19. Under section 519(c) of the act and Sec. 803.19, a 
practitioner licensed by law to prescribe or administer devices 
intended for use in humans and who manufactures or imports devices 
solely for use in the course of that individual's professional practice 
is exempt from reporting. Manufacturers of devices not being 
commercially distributed but which are being used under an 
investigational device exemption are required to report adverse events 
under parts 812 and 813 (21 CFR parts 812 and 813) and are not required 
to submit reports under part 803. Parts 812 and 813, however, require 
reporting of all adverse device effects.
    14. Many comments stated that the definition of ``MDR reportable 
event'' (Sec. 803.3(q)) is unclear, beyond the scope of SMDA, or 
otherwise in need of revision.
    The definition of ``MDR reportable event'' has been modified to 
conform to revisions made to section 519 of the act by section 5 of the 
1992 amendments. As defined in Sec. 803.3(q), the revised definition of 
``MDR reportable event'' mirrors the language of section 519(a)(1) and 
(b)(1) of the act, as amended by section 5 of the 1992 amendments.
    FDA has further clarified terms contained in the definition of an 
``MDR reportable event'' throughout this document. These include: 
``caused or contributed,'' as defined in Sec. 803.3(d) and discussed in 
section IV.B., comment 11 of this document; ``information that 
reasonably suggests that a device has or may have caused or contributed 
to a death or serious injury'' as defined in Sec. 803.20(c) and 
discussed in section IV. B., comment 11 of this document; 
``malfunction'' as defined in Sec. 803.3(m) and discussed in section 
IV.B., comment 12 of this document; ``become aware'' as defined in 
Sec. 803.3(c) and discussed in sections IV.A., comments 2 and 6, and 
IV.D., comment 27 of this document; and ``serious injury,'' as defined 
in Sec. 803.3(aa) and discussed in section IV.B., comment 21 of this 
document. The terms ``necessitated medical or surgical intervention'' 
and ``permanent,'' which are now included in the definition of 
``serious injury,'' are also clarified in this document. ``Necessitated 
medical or surgical intervention'' is discussed in section IV.B., 
comment 16 of this document. FDA believes that these added definitions 
and discussion of these terms this document provides adequate 
clarification of the term ``MDR reportable event.''
    15. A few comments stated that the definition of ``manufacturer 
report number'' (Sec. 803.3(o)), should be changed to allow flexibility 
and permit 

[[Page 63586]]
manufacturers to use their own numbers.
    The agency disagrees. A uniform numbering system is essential for 
FDA evaluation of reports, recordkeeping, filing and analyses. Because 
the manufacturer report number is based on the manufacturer 
registration number and all manufacturing sites are required to have a 
registration number, there is no additional burden on the manufacturer 
to comply with this requirement. If the manufacturer reporting site 
does not have a registration number, FDA will assign a temporary 
registration until the site is officially registered.
    16. Several comments stated that the definition of ``necessitated 
immediate medical or surgical intervention'' (proposed Sec. 803.3(o)), 
included as an element of the ``serious injury'' definition in 
Sec. 803.3(aa), which is unclear, overly broad, and unduly burdensome. 
Some of these comments suggested that the terms ``timely'' and 
``intervention'' be further defined or a standard for ``immediate 
intervention be set (e.g., within 6 hours). Other comments suggested 
that the event be reported only if significant intervention actually 
occurred.
    In light of the 1992 amendments, most of the comments relating to 
the ``immediate medical or surgical intervention'' definition are no 
longer relevant. Section 5(a)(2) of the 1992 amendments revised and 
broadened the scope of reportable events that fall within the 
definition of ``serious injury'' by deleting the immediacy requirement 
from the definition. Under the 1992 amendments' revisions, FDA must 
require that injuries be reported that necessitate medical or surgical 
intervention to preclude permanent impairment of a body function or 
permanent damage to a body structure, that have or may have been caused 
by a device, regardless of the immediacy of the surgical or medical 
intervention.
    FDA agrees with comments suggesting that an event be reported if 
significant intervention actually occurred. FDA believes, however, that 
any intervention is per se ``significant'' if it is necessary to 
preclude permanent impairment of a body function or permanent damage to 
a body structure.
    17. Many comments stated that the definition of ``patient of the 
facility'' whose serious injuries and deaths user facilities must 
report( Sec. 803.3(v)) is too broad. Several comments objected to 
including individuals being diagnosed, treated, or receiving care 
``under the auspices of'' the facility under this definition. Other 
comments objected to including employees of the facility who suffer 
death or serious injury from a device used at or by the facility as a 
``patient of the facility.'' They further asserted that FDA does not 
have clear jurisdiction over these types of employee events and that 
MDR reports would duplicate reports required by other regulations 
(e.g., Occupational Safety and Health Administration (OSHA) 
regulations). A few comments suggested that the term ``patient'' be 
further defined.
    The agency agrees that including any individuals treated or 
diagnosed ``under the auspices'' of a facility could be read very 
broadly to include certain individuals that are not intended to be 
covered by this regulation. Accordingly, FDA has revised this 
definition to include only individuals that are ``being diagnosed or 
treated and/or receiving medical care at or under the control or 
authority of the facility.''
    FDA does not agree, however, that employees of the facility who are 
injured and/or receive medical care arising from a device-related event 
at the facility should be excluded from the definition of ``patient of 
the facility,'' and that information provided to other agencies for 
work-related injuries is duplicative of information required in an MDR 
report. FDA believes that facility employees who suffer injury or death 
in a device-related event reasonably fall within the meaning of the 
requirement under section 519(b)(1)(A) of the act to report such events 
that involve a ``patient of the facility.'' To ensure the safety and 
efficacy of devices, FDA needs information required in the MDR reports 
for all device-related adverse events regardless of the individual's 
employment relationship to the facility. MDR reports are required to 
provide information that is specifically tailored to help FDA determine 
the risks posed by a certain device and whether further action may be 
necessary. Reports required by other agencies relating to work 
injuries, such as OSHA, do not provide the MDR report information that 
is necessary for FDA to make these determinations. Accordingly, there 
is no unnecessary duplication involved in reporting.
    18. A few comments stated that injuries must be reported because 
they are ``permanent,'' (proposed Sec. 803.3(q)), should exclude 
``trivial'' or ``cosmetic'' irreversible damage.
    FDA agrees in part. To improve clarity, the agency has included the 
definition of ``permanent'' with the ``serious injury'' definition 
(Sec. 803.3(aa)). The agency has also modified the definition of 
``serious injury'' to exclude trivial irreversible damage. While most 
cosmetic damage will be trivial, not all cosmetic damage would be 
considered trivial. Therefore, FDA is not excluding all cosmetic damage 
from this definition.
    19. A few comments recommended that the definition of 
``probability, probable, or probably'' in the reporting standard be 
clarified and suggested using a ``greater than 50 percent'' standard.
    As discussed earlier in this document, the 1992 amendments deleted 
the term ``probability'' from the reporting standard and revised the 
standard for manufacturers and user facilities. Therefore, this 
definition has been removed from the final rule.
    20. A few comments stated that the definition of a ``remedial 
action,'' (Sec. 803.3(y)), which is required to be reported under 
Secs. 803.53(a) and 803.52(f)(7), is unclear. One comment suggested 
that the definition be deleted; another suggested that it be removed 
from the user reporting form.
    The agency does not agree that this definition should be deleted. 
The agency should be aware of remedial actions taken in response to 
reportable events in order to thoroughly evaluate the event. However, 
the definition has been reworded for clarity. Also, the request for 
remedial action information has been removed from the user facility 
section of the final reporting form (FDA Form 3500A) because user 
facilities do not ordinarily undertake remedial actions. The revised 
definition of ``remedial action'' appears in Sec. 803.3(y).
    21. Several comments stated that the definition of a reportable 
``serious injury or serious illness'' (Sec. 803.3(aa)) is overly broad 
and needs to be better defined. Another comment suggested that these 
terms be deleted from the manufacturer and distributor report forms 
altogether. One comment suggested that ``temporary damage'' be excluded 
from the definition.
    The agency disagrees with comments that requirements to report 
serious injuries or illnesses should be deleted from the manufacturer 
and distributor reporting form. Section 519(a)(1)(a) of the act 
requires manufacturers to report serious injuries. Nor does FDA agree 
that the definitions of these terms are overly broad. The regulatory 
definition in Sec. 803.3(aa) of the terms ``serious illness'' and 
``serious injury'' are derived directly from the statutory definitions 
provided in section 519(a)(2) and (b)(5)(B) of the act, as amended by 
the 1992 amendments.
    The SMDA added section 519(b)(5)(B) to require that user facilities 
report ``serious illnesses'' as well as ``serious injuries.'' The 1992 
amendments 

[[Page 63587]]
amended section 519(a)(2) to require that manufacturers report only 
``serious injuries.'' The statutory definitions of the terms ``serious 
injury'' and ``serious illness,'' however, are identical. (See section 
519(a)(2) and (b)(5)(B) of the act.) The legislative history of the 
1992 amendments indicates that ``the term 'injury' probably covers any 
illness that could be caused by a device * * *.''(138 Congressional 
Record H 3884 (1992).)
    In accordance with the statutory definition, FDA has defined 
``serious injury'' to mean an injury or illness that is: (1) Life-
threatening; (2) results in permanent impairment of a body function or 
permanent damage to body structure; or (3) necessitates medical or 
surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure.
    As stated in response to comments described in section IV.B., 
comment 18 of this document, FDA has further clarified the definition 
of serious injury by clarifying the term ``permanent'' within the 
definition in Sec. 803.3(aa). Because section 519(a)(2) and (b)(5)(B), 
as amended by the 1992 amendments, identically defines the terms 
``serious injury'' and ``serious illness'' FDA has revised the 
definition of the term ``serious injury'' to include ``serious 
illness.''
    FDA does not agree with the comment stating that temporary damage 
should not fall within the definition of ``serious injury.'' Section 
519(a)(2)(A) and (b)(5)(B) define serious injury to include any event 
that is ``life-threatening.'' Because life-threatening events may 
include temporary damage, FDA believes that life-threatening events 
that may have been caused by a device must be reported, regardless of 
whether the damage was ``temporary.''
    22. One comment stated that the definition of ``user facility 
report number'' (Sec. 803.3(dd)) needs to be more specific, especially 
regarding leading zeroes in the number.
    The agency agrees and has modified the definition for clarity. The 
revised definition appears in Sec. 803.3(dd).
    23. Several comments requested that the terms: ``become aware,'' 
``expected life,'' and ``shelf life'' be defined.
    FDA agrees. These definitions have been included in the final rule 
and appear in Sec. 803.3(c), (i), and (bb) respectively. For further 
discussion of the term ``become aware,'' see sections IV.A., comments 
2, 6, and IV.D., comment 27 of this document.

C. Section 803.9--Public Availability of Reports

    24. Many comments expressed concern over confidentiality of the 
reports.
    The agency is aware of confidentiality concerns and will protect 
the confidentiality of information to the fullest extent allowed under 
the law. FDA is generally required, under the Freedom of Information 
Act (FOIA) (5 U.S.C. 552), to make publicly available reports received 
under this final rule. Public availability of such reports is governed 
by FOIA and part 20 (21 CFR part 20). Before a report is made publicly 
available, FDA, in accordance with FOIA and part 20 as promulgated in 
1984, will delete from the report information whose disclosure would 
constitute an invasion of personal privacy (see 5 U.S.C. 552(b)(6); 
Sec. 20.63) or information that constitutes trade secret, confidential 
commercial or financial information (see 5 U.S.C. 552(b)(4); 
Sec. 20.61). Persons who are subjects of the reports, however, can 
receive all information in the report concerning themselves, except for 
trade secret, confidential commercial or financial information.
    FDA has modified Sec. 803.9 in this final rule to clarify that the 
identity of a third party who submits a voluntary adverse event report, 
such as a physician or other health care professional, will be 
protected. This revision does not add any new protection for voluntary 
third-party reporters. It merely clarifies that the existing protection 
afforded to voluntary reporters under Sec. 20.111 is applicable to MDR 
reports.
    Revised Sec. 803.9 incorporates the confidentiality provisions 
relating to user facility reporting in section 519(b)(2) of the act, as 
added by the SMDA. Specifically, Sec. 803.9(c) states that FDA may not 
disclose the identity of a device user facility except in connection 
with : (1) An action brought to enforce section 301(q) of the act (21 
U.S.C. 331(q)), which includes the failure or refusal to furnish 
material or information required by section 519 of the act; (2) a 
communication to a manufacturer of a device which is the subject of a 
report of a death, serious injury or other significant adverse device 
experience required by a user facility under Sec. 803.30; (3) a 
disclosure relating to a manufacturer or distributor report which is 
required under section 519(a) of the act; and (4) a disclosure to 
employees of the Department of Health and Human Services, to the 
Department of Justice, or to duly authorized committees and 
subcommittees of the Congress.
    As stated above, Sec. 803.9, which is derived from the statutory 
language in section 519(b)(2)(C) of the act, allows disclosure of the 
user facility's identity when disclosure is required under provisions 
requiring manufacturer and distributor reporting. The legislative 
history of section 519(b)(2)(C) of the act states that this section is 
not intended to affect public access to information contained in MDR 
reports to FDA, and that the full requirements of reporting under 
section 519(a) of the act (the manufacturer and distributor reporting 
provisions), will apply. If a manufacturer chooses to forward a user 
report to FDA, that will then constitute a report described in section 
519(a) of the act, not a report described in section 519(b) of the act, 
for purposes of public access to the contents of the report. (H. Rept. 
101-808, 101st Cong., 2d sess., pp. 21-22). Accordingly, if information 
in a required user facility report is submitted as part of a 
distributor or manufacturer report, the information relating to the 
identity of the user facility would be disclosable because the report 
would be submitted under section 519(a) of the act. FDA notes that, in 
accordance with part 20 and section 519(b) of the act, the agency will 
not disclose the identity of the user facility physicians, persons 
designated by the user facility to submit reports, or other user 
facility employees, although the identity of the user facility may be 
disclosed.
    25. Many comments expressed concern that the regulation will 
increase liability and that the availability of reports will lead to 
civil litigation.
    Although FDA is aware that litigants in civil suits may attempt to 
use information in adverse event reports as evidence in product 
liability suits, FDA does not have any information as to whether the 
information from reports will actually lead to the initiation or 
increase of civil litigation. Section 519 of the act requires user 
facilities and manufacturers to submit reports of adverse events. While 
these reports may have some effect on a reporter's liability, these 
regulations are required to implement statutory requirements. They are 
also necessary to make FDA aware of unsafe devices and better enable 
the agency to take appropriate action to safeguard the public health. 
With respect to user facilities, section 519(b)(3) of the act provides 
some protection against liability in that it prohibits the 
admissibility of device user facility adverse event reports into 
evidence for civil actions involving private parties, except where the 
party making the report had knowledge that information in the report is 
false.

[[Page 63588]]

    With respect to manufacturers and distributors, FDA has attempted 
to provide protection from liability by clearly stating in Sec. 803.16 
of this final rule, and including a statement on FDA Form 3500A, that 
the submission of a report does not constitute an admission that the 
user facility, manufacturer/distributor, product, or medical personnel 
caused or contributed to the event. Moreover, in the Federal Register 
of April 3, 1995 (60 FR 16962), FDA issued a final rule that became 
effective on July 3, 1995, that protects the identity of voluntary 
reporters by preempting State laws or other requirements requiring or 
permitting disclosure.
    26. Comments objected to providing FDA with proprietary 
information.
    FDA may require the submission of certain proprietary information 
because it is necessary to fully evaluate the adverse event. 
Proprietary information will be kept confidential in accordance with 
Sec. 803.9, which prohibits public disclosure of trade secret or 
confidential commercial information, and in accordance with the FOIA 
and FDA regulations in 21 CFR part 20.

D. Reports by Device User Facilities (Part 803, Subpart C)

    27. Several comments stated that 10 days is too short a time period 
for user facilities to report adverse events properly. One comment 
suggested that the 10-day ``clock'' for reporting should commence when 
the facility completes its investigation and determines that an event 
is reportable.
    FDA cannot agree because the 10-day time period is the maximum time 
allowed by the statute. (See section 519(b)(1)(A) of the act.) However, 
this comment raises the issue of when the reporting ``clock'' starts. 
In the preamble to the November 1991 tentative final rule, FDA proposed 
to consider a user facility to have ``become aware'' of reportable 
events only when it has sufficient information to make a determination 
that a report is required, and that this commences the 10-day reporting 
period. (See the notice of availability of the MEDWATCH adverse event 
reporting form (FDA Form 3500A) in the Federal Register of June 3, 1993 
(58 FR 31596.))
    FDA has reevaluated the issue of when a user facility should be 
considered to ``become aware'' of information that triggers the 
reporting requirements and has determined that user facilities should 
be considered to have ``become aware'' of information that triggers 
reporting requirements when they first receive a report. The agency 
does not believe that information-gathering required of user facilities 
is sufficiently burdensome or time consuming to justify triggering the 
10-day timeframe any time after they receive a report of an adverse 
event. A user facility, unlike a manufacturer, is not required to 
provide any information that is not in its possession. For further 
discussion on when user facilities are considered to have ``become 
aware'' of an event, see section IV.A, comment 2 of this document.
    28. Several comments suggested that the user/operator error 
reporting requirement be eliminated.
    As stated in section IV.A., comment 3 of this document, the 
language of the SMDA as amended by the 1992 amendments requires 
reporting in all instances where the facility becomes aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to certain device-related adverse events. FDA 
needs to be aware of events that are related to user error any time 
such error may have caused or contributed to a reportable event. By 
receiving information on device user problems, FDA can determine 
whether additional measures are necessary to resolve such problems, for 
example, relabeling or a redesign of the device.
    29. One comment suggested that all reports be sent only to FDA.
    FDA does not agree. This regulation merely implements section 
519(b) of the act, which requires user facilities to submit deaths to 
FDA and the manufacturer, and serious injuries to the manufacturer or 
FDA, if the identity of the manufacturer is unknown.
    30. Some comments suggested that an anonymous reporting path be 
provided for reporting directly to FDA.
    FDA disagrees. It is important that both FDA and the manufacturer 
know the identity of the user facility in case followup information is 
needed. As discussed in section IV.C., comment 24 of this document, the 
act does provide some protection of the identity of user facilities.
    31. Several comments requested clarification of the terms ``adverse 
events,'' ``formally affiliated,'' and ``user error.''
    Adverse events are those events that may be related to an FDA-
regulated product and which have a negative or harmful effect on the 
user or recipient of the product's use. The only adverse events 
required to be reported under this regulation, however, are ``MDR 
reportable events'' as defined in Sec. 803.3(q) of the final rule.
    The term ``formally affiliated'' means individuals who are employed 
by a user facility or medical personnel who have admitting, practicing, 
or equivalent privileges at a user facility. Reporting requirements for 
user facilities are triggered when medical personnel who are employed 
by or otherwise ``formally affiliated'' with the facility, receive 
information or become aware of information that reasonably suggests a 
reportable event has occurred.
    The term ``user error'' means any error made by the person using 
the device. A user error may be the sole cause or merely contribute to 
a reportable adverse event.
    32. One comment suggested that FDA provide user facilities with 
manufacturer and agency contacts. Another comment suggested that a 
hotline be established for reporting.
    It would be very difficult for FDA to establish and maintain up-to-
date manufacturer ``contact'' lists for device user facilities. The 
agency, however, will consider publicizing a list of firm contact names 
and telephone numbers. Although there is no requirement for telephone 
reporting in this regulation, emergency situations can be handled in 
accordance with Sec. 803.12(c) of this final rule.
    33. One comment asked how foreign user facilities will be affected 
by these provisions.
    Only those user facilities located outside the United States which 
are operated by the U.S. Government are required to report under this 
regulation.
    34. Comments suggested that the requirements for semiannual reports 
be deleted because they are redundant. Other comments suggested that no 
semiannual report be required if no reports had been submitted during 
that period.
    Semiannual reports are required by section 519(b)(1)(C) of the act 
and therefore the requirement cannot be deleted. Under Sec. 803.33(c), 
the user facility is not required to submit a semiannual report if no 
reportable events occurred during the reporting period.

E. Reports by Manufacturers (Part 803, Subpart E)

    35. One comment suggested that manufacturer reporting of ``planned 
remedial actions'' be deleted. Another comment stated that remedial 
action often occurs after the reporting deadline, and therefore cannot 
be included in the report.
    Remedial actions taken after a reporting deadline can be submitted 
to the agency via a supplemental report. The individual adverse event 
reports required under the final rule, with the exception of 
circumstances requiring 5-day reports, do not require information 

[[Page 63589]]
concerning ``planned remedial action'' because supplemental reports and 
reports of Removals and Corrections will provide the agency with the 
same information. Remedial actions that are necessary to prevent an 
unreasonable risk to the public health should be reported as 5-day 
reports under to Sec. 803.53.
    36. Several comments requested that manufacturers be exempt from 
the requirement of submitting supplemental reports because they are 
vague and burdensome.
    FDA does not agree. The supplemental report does not impose any 
significant additional burden under Sec. 803.56 because it requires 
information that a manufacturer was required to submit on its initial 
report, but did not do so because such information was unknown or 
unavailable at the time of the report. This information may include, 
for example, the results of a firm's investigations that may not have 
been completed at the time of the initial report, or any other required 
information that the manufacturer becomes aware of after filing a 
report. The information required is not vague and is clearly specified 
in Secs. 803.52 and 803.56. Both initial and supplemental reports are 
to be submitted on FDA Form 3500A or electronic equivalent.
    Under Sec. 803.15, FDA may also require supplemental information 
(termed ``request for additional information'' in the final rule) in 
addition to that required on other reports specified in this part. FDA 
believes these reports are not unduly burdensome given that they will 
be required only in instances when the agency determines that the 
protection of the public health requires such information. In such 
cases, FDA will specify the type of information needed.
    37. One comment stated that the quality of information will 
decrease if manufacturers are denied access to products.
    FDA agrees that manufacturers should evaluate a device problem if 
they have access to the device. FDA has no authority to require that a 
device be returned to the manufacturer, but the agency encourages 
device users, when possible, to permit access or return the device to 
the manufacturer for evaluation.
    38. One comment suggested that manufacturer reports should be sent 
to user facilities, as well as to FDA.
    FDA does not agree. FDA believes that user facilities do not have 
the appropriate resources or personnel to properly evaluate the public 
health significance of manufacturers' reports. FDA is the proper entity 
to evaluate MDR information to determine whether further action, 
including notification to user facilities or others of device risks, is 
appropriate.
    39. A few comments suggested that the 1984 requirements for 
manufacturer reporting should be retained to avoid possible confusion 
caused by the creation of a new standard. Other comments called for the 
elimination of the monthly reporting requirement.
    As discussed earlier in the preamble, subsequent to the issuance of 
the November 1991 tentative final rule, the 1992 amendments modified 
the language for reporting standards that apply to user facilities, 
manufacturers, and importers. The language used in the November 1991 
tentative final rule no longer reflected the statutory language, as 
modified. In this final regulation, FDA has revised the reporting 
standard to reflect the statutory language added by the 1992 
amendments. This statutory reporting standard is substantially similar 
to the manufacturer reporting standard in the 1984 regulations.
    Although the final regulation retains the reporting standard 
language from the 1984 regulation referenced above, it incorporates 
many changes from that regulation that are intended to enhance the 
quality of the reports received and increase the efficiency of FDA's 
report processing. FDA believes the benefits of changes implemented by 
the new regulation far outweigh the limited costs for manufacturers to 
familiarize themselves with the new requirements.
    Under the final rule, manufacturers have 30 days after they become 
aware of an MDR event (with the exception of 5-day reports required by 
Sec. 803.53) to report the event to FDA. FDA, however, has eliminated 
the portions of monthly reporting requirements, as proposed, that would 
have required manufacturers to submit, in addition to individual 
adverse event report information, an evaluation of adverse events 
consisting of the results of a statistically-based trend analyses 
conducted by the manufacturer, a discussion of the underlying 
methodologies used, a description of any unusual or unexpected events, 
and a description of remedial action taken.
    As proposed, the greatest benefit of the evaluation portions of the 
monthly report would have been the overview of adverse experience 
trends it would provide. However, FDA has reevaluated the benefits of 
these monthly reports, and determined that the agency would incur the 
costs of data entry regardless of the industry's analysis, and that a 
computer program for the analysis of the data may be used at a 
relatively low cost to the agency. Furthermore, the agency anticipates 
that internal trending analysis will be conducted as part of a 
manufacturer's CGMP. Any remedial actions presenting an unreasonable 
risk of substantial harm that are undertaken based upon internal trend 
analyses are reportable in a 5-day report. Other essential information 
under the proposed monthly report will also be made available to the 
agency under the CGMP regulations, and would be made available to FDA 
under the proposed reports of removals and corrections regulation.
    The final regulation will also allow FDA to receive information 
about reports sooner than the monthly reports as previously proposed. 
The proposed regulation allowed the manufacturer up to 2 months from 
the date of an adverse event to submit the monthly report. For example, 
under the proposed regulation, information received by the manufacturer 
on January 1 would have been due in a monthly report in March. Under 
the final regulation, the manufacturer will submit all reports of 
adverse events within 30 days of the event. Accordingly, under the 
final rule, information about a reportable event the manufacturer 
received on January 1, would have to be reported within 30 days.
    FDA believes that the timeframes under the final regulation allow 
sufficient time for completing individual reports because the 
manufacturer would no longer be required to compile the trend analysis 
and other evaluations as previously proposed for the monthly reports. 
FDA also believes that the monthly reporting of individual adverse 
events in the final rule will achieve FDA's goal of obtaining better 
quality initial reports from manufacturers by allowing more time to 
complete the reports than allowed under the 1984 regulation. 
Nonetheless, the public health will benefit under the final rule 
because FDA will receive reports of individual events sooner than under 
the proposed rule.
    40. One comment objected to the use of identification (ID) numbers 
on the reporting form, claiming they are unnecessary.
    The agency disagrees. Report ID numbers are essential to FDA's 
ability to efficiently audit, process, analyze and evaluate MDR data. 
One of the major deficiencies of the current system is its inability to 
consistently identify similar devices and other data elements that 
facilitate the comparison of adverse events. The use of device ID 
numbers (Secs. 803.32(c)(6) and 803.52(c)(6)), user facility and 
manufacturer report numbers (Secs. 803.3(dd) and (o), respectively)), 
and event codes 

[[Page 63590]]
(discussed in section IV.F., comment 52 of this document) will 
facilitate information access and retrieval, and increase the agency's 
ability to evaluate the information.
    41. Comments stated that the requirement for firms to compare 
events associated with the use of their devices, in order to perform 
trending studies, should be removed.
    The agency agrees in part and has deleted MDR trending reporting 
requirements, as discussed in section IV.E, comment 39 of this 
document. Under the prior reporting regulation, FDA has faced 
difficulties in making an effective determination of the significance 
of many device failures, because the reports did not include the total 
number of similar devices in current use or similar failures. Such 
information, which is required in baseline reports, provides the agency 
with information regarding the rate of adverse events. An understanding 
of device failure rates is essential for the agency to determine the 
level of risk involved, and the appropriate regulatory or other public 
health response.
    42. One comment suggested that instead of the manufacturer 
indicating to whom the information was reported in the monthly 
reporting form, it is more important to indicate by whom it was 
reported.
    The agency agrees in part. As noted above, the monthly report 
requirement, as proposed, has been eliminated; however, information 
about the initial reporter is required on the individual adverse event 
MEDWATCH form (FDA Form 3500A or an FDA approved electronic 
equivalent).
    43. One comment objected to the requirement to report problems 
found in the scientific literature. Another comment objected to 
reporting anything except problems found in the scientific literature 
or from research.
    Any information which reasonably suggests that a reportable event 
occurred is important to evaluate the risks of a device, regardless of 
the source. Although reports in the scientific literature or research 
are usually not proximate in time to actual events, the information 
often represents the results of cumulative observations and experience, 
and provides important information to FDA about device safety and 
effectiveness.
    44. One comment stated that the manufacturer reporting requirements 
are inappropriate for device sales made directly to the patient.
    The agency disagrees. The act does not provide any restrictions or 
limitations with respect to how the device was marketed. FDA would lose 
a valuable source of information if manufacturers of devices sold 
directly to patients, such as many apnea monitors or home use glucose 
monitors, were excluded from this requirement. All information 
concerning device-related deaths, serious injuries or other reportable 
events is equally important, regardless of how the device is marketed.
    45. One comment stated that there is no relationship between 
devices shipped by the manufacturer and those on the market, as the 
devices may have been altered; therefore, the manufacturer should not 
be responsible for reporting events involving such devices.
    The agency disagrees. Devices in commercial distribution are 
presumed to be the same devices shipped by the manufacturer. If a 
manufacturer receives information about an MDR event involving a device 
that has been altered, the information must nevertheless be forwarded 
to FDA with an explanation that the device has been altered.
    46. One comment suggested that a U.S.-designated agent should be 
responsible for reporting on behalf of foreign manufacturers.
    FDA's November 1991 tentative final rule proposed that U.S.-
designated agents should be required to report for foreign 
manufacturers. This requirement has been adopted in Sec. 803.58.
    47. One comment suggested that the manufacturer should disclose the 
results of event evaluations to distributors of the device.
    FDA does not agree. Disclosure of evaluations would be burdensome 
and may result in release of information that is protected under other 
laws and regulations. FDA will inform the public, including 
distributors, of steps necessary to protect the public health if the 
agency determines such steps are necessary.

F. User Facility and Manufacturer Reporting Forms for Individual 
Adverse Events (Secs. 803.32 and 803.52)

    48. Several comments asserted that this section is costly, 
complicated, overly broad, unacceptably burdensome and not consistent 
with the SMDA as it requires the reporting of information not required 
or supported by the SMDA.
    The agency disagrees. As stated earlier in the preamble, FDA has 
adopted the use of a single reporting form for most FDA-regulated 
products, in order to facilitate the cost-efficient submission of 
information required by or consistent with the provisions of the SMDA. 
The agency agrees that the data elements could be simplified and has 
modified the form after consideration of comments to the February 1993 
notice submitted by medical device trade associations and other 
regulated or affected entities. FDA anticipates that the consolidated 
form will facilitate the submission, and improve the quality, of 
adverse event reports. During the initial period of its use, FDA will 
continue to closely monitor comments and suggestions received from 
interested parties regarding the reporting form, and will consider 
additional modifications to further improve the form as the need 
arises.
    49. One comment stated that it will be difficult to find 
manufacturer reporting forms. Another comment stated that the report 
form, distributed as a draft to certain interested parties, is not 
compatible with the use of a word processor.
    The MEDWATCH forms (FDA Forms 3500 and 3500A) are already in wide 
distribution and were published in the Federal Register on June 3, 
1993. Information about the MEDWATCH form, and how to obtain it, is 
provided Secs. 803.10 and 803.11.
    Although a word processor would be able to fill the fields on FDA 
Form 3500A with great difficulty, the agency has made provisions for 
the submission of reports on alternative (electronic) media which would 
obviate the need for printing the form from a word processor.
    50. Several comments were concerned with the adversarial and 
litigation issues which may be raised by reporting on the forms. In 
this regard, a few comments suggested deleting all items that require 
speculation and judgment in reporting, removing the signature block, or 
adding a disclaimer to the form.
    As stated in section IV.C., comment 25 of this document, although 
FDA is aware that these reports may have some effect on liability, the 
required information is necessary to implement the agency's statutory 
responsibilities. Under the statute, user facilities and manufacturers 
must report adverse events when a device ``may'' have caused or 
contributed to the event. Accordingly, FDA does not have the discretion 
to require reporting only when a definitive causal relationship is 
established. Furthermore, adoption of such a standard would preclude 
FDA from receiving information that would help the agency assess the 
risks associated with devices.
    FDA has removed the signature block on the form. FDA has provided a 
disclaimer statement on the reporting form, as discussed in section 
IV.C., comment 25 of this document.
    51. Some comments suggested that the evaluation of events or 
reports be 

[[Page 63591]]
left to FDA, the manufacturer or another third party. Other comments 
suggested that the manufacturer should not be required to verify data 
or provide data about which it has no knowledge. Other comments 
suggested that user facilities do not have the appropriate expertise to 
analyze events or make determinations concerning the reportability of 
events.
    FDA agrees that user facilities should not be required to conduct 
in-depth analyses of events and has deleted certain requirements 
regarding information relating to evaluation and testing. User 
facilities serve principally as conduits of information and thus are 
required only to fill out information that is known to them. However, 
the statute and regulations still require user facilities to make an 
initial determination as to whether an event should be reported under 
the regulation's criteria. Accordingly, FDA has retained elements that 
relate to this determination. In Sec. 803.30, FDA explains user 
facilities' obligations to obtain information about adverse events.
    FDA believes that the manufacturer who is responsible for placing a 
device into interstate commerce is the appropriate entity to initially 
investigate and evaluate whether, and why, the device may have caused 
or contributed to a reportable event or malfunctioned and that such 
malfunction is a reportable event. In order for FDA to determine 
whether the risk posed by a device necessitates action to protect the 
public health, the manufacturer is also required to verify data and 
provide missing information after investigating the event. If after an 
investigation the information cannot be determined, a manufacturer must 
explain in the MDR report why the information cannot be obtained.
    The agency agrees that an analysis of reports for patterns and 
trends may be more appropriately conducted by the manufacturer or FDA. 
FDA will conduct statistical analyses of report information submitted. 
The agency expects that manufacturers will conduct trend analyses as 
part of their CGMP.
    52. Several comments suggested that numerical event and evaluation 
codes should not be used on the adverse event reporting form. Other 
comments stated that the codes lacked accuracy or were insufficient.
    The agency disagrees. It is the manufacturer's responsibility to 
evaluate reports to determine causation. It is reasonable that an 
evaluation will result in the assignment or identification of failure 
modes and that these can be communicated to FDA in the form of a 
structured vocabulary or ``coded'' data. In developing these codes, the 
agency has used the experience gained from reviewing nearly 400,000 
reports submitted since 1984. The use of these codes is essential to 
the rapid evaluation of device risks and processing of reports by 
computer. Regardless of whether the codes are specific enough to 
describe a particular event, the event must be fully described in the 
narrative section of the reporting form.
    The list of codes for use with the final form (FDA Form 3500A or 
FDA approved electronic equivalent) has been expanded for completeness 
and modified to improve accuracy. The agency will continue to improve 
the accuracy of its codes as needed.
    53. Various comments suggested that the following elements be 
removed from the form: Degree of certainty, labelled usage, result of 
analysis, list of other devices, purchase date, service and maintenance 
items, event description, and medical status of the patient.
    FDA has deleted requirements for user facilities and manufacturers 
to report service and maintenance information and to state the degree 
of certainty concerning whether the device caused or contributed to an 
adverse event. FDA believes the burden of requiring this information 
would usually outweigh the benefit of assessing the cause of an adverse 
event. FDA, however, has retained the requirements for manufacturers to 
report use indications specified in the labeling and device analyses 
because this information is valuable in determining causation of the 
event. FDA has deleted the requirements to report these elements for 
user facilities because the agency believes the manufacturer is the 
most appropriate source for this information. All user facilities and 
manufacturers will still be required to provide information regarding 
concomitant product use, age of the device, event description and 
certain patient information. FDA believes this information is important 
to assess adverse events and should be available to user facilities as 
well as manufacturers.

G. Manufacturer Annual Certification Report (Sec. 803.57)

    54. A few comments stated that this section is redundant, overly 
broad and burdensome, exceeds the scope of the SMDA and should be 
deleted. Another comment suggested that certification be limited to 
events involving class III devices.
    The agency cannot agree. Section 519(d) of the act states that each 
manufacturer required to make reports under section 519(a) of the act 
must submit annual statements certifying the number of reports filed or 
that no reports were filed during the previous 12-month period. The 
provisions of this regulation pertaining to the statutory certification 
requirement merely explain what information should be contained in the 
submission. Furthermore, FDA does not agree that certification should 
be limited to reports about adverse events involving class III devices. 
Any device, regardless of its classification, can pose serious risks 
that need to be reported to FDA.
    55. Some comments suggested that the certification be limited to 
the number of reports actually filed, and that liability should attach 
only in instances of known reporting violations.
    The agency disagrees. The purpose of this provision is to ensure 
reporter compliance with MDR requirements by certifying that all 
reportable events have been submitted. Such purpose would be thwarted 
and the certification requirement rendered meaningless if it were 
limited to simply certifying the number of reports submitted instead of 
all reportable events known to the certifying entity. The legislative 
history of section 519(d) of the act references a U.S. General 
Accounting Office recommendation that the certification state that the 
reporter ``filed a specific number of reports * * * and that the firm 
received or became aware of information concerning only these events.'' 
(H. Rept. 808, 101st Cong., 2d sess. 23 (1990)).
    Accordingly, consistent with Congress' intent, FDA is requiring 
certification that all known reportable events were reported. This 
requirement does not impose liability for adverse events that are 
unknown to the reporter because the reporting requirements are 
triggered only when the reporting entity ``becomes aware'' of a 
reportable event.
    56. Several comments stated that the purpose of certification 
should be to verify reports, not to certify with absoluteness; 
therefore the standard should be changed to ``reasonably certain'' and 
a disclaimer should be added.
    The agency disagrees. Section 519(d) of the act specifically states 
that firms shall certify, not verify their reports. As discussed in the 
previous paragraph, the purpose of this provision is to ensure that the 
reporter complies with the law by certifying that it has submitted all 
the reports it was required to submit. This purpose would not be 
accomplished by verifying the report.
    57. One comment asked for clarification about who is required to 
certify. Another comment suggested that 

[[Page 63592]]
the signature block be for the certifier and contractor as well.
    The agency agrees with the need for clarification regarding who 
must certify and has incorporated language in the final rule to address 
this suggestion. Under the final rule, the president, chief executive 
officer, executive officer, U.S.-designated agent of a foreign 
manufacturer or other official most directly responsible for the firm's 
operations shall certify reports submitted under section 519 of the 
act.
    58. Two comments requested that decentralized certification be 
allowed for multisite firms. Another comment suggested that centralized 
reports be used in this situation.
    Manufacturers have the option of certifying centrally or on a 
decentralized basis. Firms deciding to certify centrally must identify 
the sites covered by the certificate by name and registration number or 
FDA-assigned identification number.

H. Additional Requirements (Sec. 803.15)

    59. A few comments asserted that these provisions are vague and 
inappropriate in the absence of a device failure complaint.
    The agency disagrees. This provision refers to submission of 
additional information after an adverse event report has been filed. 
Accordingly, FDA would not be requesting information in the absence of 
a device failure or complaint.
    60. A few comments objected to the idea of giving FDA unlimited 
access to data. One comment wanted to restrict FDA's right to copy data 
and another wanted an appeal process.
    FDA does not agree with comments proposing to restrict or limit the 
agency's access to additional information about adverse events. Under 
section 704(e) of the act, every person who is required to maintain 
records under section 519 of the act and every person who is in charge 
or custody of such records must permit FDA at all reasonable times to 
have access to and to copy and verify such records. Failure to provide 
such information may be a violation of section 301 of the act and may 
subject a person to civil or criminal penalties. Section 704(e) of the 
act does not limit in any way the types of device records maintained 
under section 519 of the act that FDA may inspect.
    FDA does not agree that the agency should be required to provide an 
appeal process with respect to requests for additional information. As 
described above, FDA has statutory authority to require additional 
information concerning adverse events. Moreover, such information needs 
to be provided as quickly as possible to enable FDA to take appropriate 
action.
    61. Several comments suggested the regulation be modified to remove 
the requirement that each reportable event be investigated because in 
some instances an investigation is unnecessary.
    The agency disagrees. All reportable events must be investigated by 
the manufacturer. The scope of an investigation may vary according to 
the circumstances; however, an investigation must be able to adequately 
assess the cause of the event. Sections 820.162 and 820.198 of FDA's 
CGMP regulations require manufacturers to review, evaluate and 
investigate any complaint involving the failure of a device to meet its 
performance specifications or involving injury, death, or any hazard to 
safety. FDA considers any event that must be reported under this part 
to be a death, injury, or hazard to safety.

I. Exemptions, Variances, and Alternative Reporting Requirements 
(Sec. 803.19)

    62. One comment asked that alternative reporting requirements under 
the current MDR system be incorporated into this regulation. One 
comment stated that the criteria for alternative reporting should be 
clarified.
    FDA has incorporated the alternative reporting options from the MDR 
regulation issued in 1984 and expanded the options available in this 
regulation. Under the final regulation, FDA may grant a written 
exemption, variance, or alternative to some or all of the requirements 
when it determines compliance with all MDR requirements is not 
necessary to protect the public health. Examples of situations include: 
(1) Devices for which FDA is already aware of a type of malfunction and 
appropriate action has been taken to protect the public health, such as 
a recall, removal, or other correction; (2) adverse events that are 
known and well documented, are occurring at a normal rate, and do not 
justify the initiation of remedial action; and (3) device events 
occurring on an infrequent basis or where a longer period for 
investigation or followup is appropriate and necessary.
    In these cases, FDA may impose conditions on its approval of an 
exemption, variance, or alternative reporting mechanism, including the 
requirement to report on a less frequent basis than otherwise required 
or to provide summary data rather than individual reports. The final 
regulation, upon its effective date, will supersede all previously 
granted exemptions and variances from the 1984 reporting requirements. 
The agency intends to review all current exemptions and variances and 
notify relevant parties about the status of their exemptions and 
variances and the additional steps that may be necessary to conform to 
the new requirements effected by this regulation.
    63. A few comments stated the criteria for exemption are unclear, 
especially with respect to investigational device exemptions, and thus 
create a loophole.
    The criteria for exemptions (Sec. 803.19) are based upon 
interpretations of the act as to the types of entities Congress 
intended should be subject to reporting. FDA believes these exemptions 
are reasonably clear. The exemptions specifically granted under this 
final regulation are the same as those in the MDR regulation issued in 
1984. Devices subject to investigational device exemptions are subject 
to reporting under the regulations governing that process (parts 812 
and 813). The exception to this are devices with investigational device 
exemptions that are approved for export. These devices are considered 
to be in commercial distribution and, therefore, subject to MDR.

J. Where To Submit a Report (Sec. 803.12)

    64. There were only two comments on this section. One suggested 
that ``MDR'' be added to the mailing address. The other recommended the 
use of electronic reporting.
    The agency agrees with these comments. ``MDR'' has been added to 
the mailing address. In addition, the agency, with prior approval, will 
accept required reports submitted electronically or on reporting media 
such as magnetic disc or tape in accordance with Sec. 803.14(a). The 
agency is in the process of developing standards, guidelines, or 
procedures for the format to be used with electronic reports. Once 
available, any electronic reporting system meeting such criteria will 
be deemed to have prior FDA approval.

K. Written MDR Procedures (Sec. 803.17)

    65. A few comments requested additional guidance on written MDR 
procedures.
    FDA agrees and has developed guidance concerning MDR procedures. 
Requests for this guidance should be directed to:
    Division of Small Manufacturers Assistance (HFZ-220), Office of 
Health and Industry Programs, Center for Devices and Radiological 
Health, 1350 Piccard Dr., Rockville, MD 20850. 

[[Page 63593]]

    Copies can also be obtained from an electronic docket maintained by 
the Division of Small Manufacturers Assistance. This system can also be 
accessed by dialing: 1-800-252-1366 or 301-594-2741. Persons wishing to 
obtain the guidance document via this system must have a video terminal 
or a personal computer with communication software (VT emulation) and a 
modem that can operate at a baud rate of 1200, 2400, 4800, or 9600. 
Persons wishing to transfer files from the electronic docket must use 
the KERMIT file transfer protocol.
    66. One comment requested that the requirement for staff education 
be deleted.
    The agency agrees and, as stated previously in this preamble, has 
removed this requirement from the final regulation.
    67. One comment objected to the requirement for written procedures. 
Another comment objected to FDA having access to the firm's procedures.
    The agency disagrees. Written procedures are essential to the 
development of a standard, institutional reporting program. FDA also 
needs access to such procedures so it can conduct an adequate audit of 
user facility and manufacturer compliance with MDR.
    68. One comment requested clarification of the term ``information 
that facilitates a submission'' for which documentation and 
recordkeeping requirements were proposed.
    ``Information that facilitates the submission [of a semiannual 
report]'' refers to any information that was evaluated for the purpose 
of preparing a semiannual report or certification. The regulation has 
been revised in Sec. 803.17 to clarify this point.
    69. One comment stated that these provisions do not address the 
penalties for failure to comply.
    FDA intends to enforce this regulation and will take appropriate 
action against any firm or facility that does not comply. Violations 
may result in criminal prosecutions and/or civil remedies such as 
seizure, injunction, recall, and civil penalties. FDA's enforcement 
mechanisms and penalties for noncompliance are detailed in the preamble 
to the November 1991 tentative final rule (56 FR 60024 at 60029 through 
60030).

L. Files (Sec. 803.18)

    70. Several comments complained that these requirements are overly 
broad, burdensome, and beyond the scope of the SMDA.
    FDA does not agree. Sections 519 and 701 of the act provide FDA the 
authority to require user facilities and manufacturers to maintain 
records to ensure that devices are not adulterated or misbranded. The 
file requirements are necessary to enable FDA to: (1) Further 
investigate potentially adulterated or misbranded devices to determine 
the cause of adverse events; (2) verify information received; and (3) 
ensure compliance with the regulations. These filing requirements will 
also enable the reporting entity to more readily identify causes of 
problems associated with devices so they can take appropriate actions.
    71. Several comments expressed concern about public access and a 
loss of confidentiality stating that these will lead to increased 
lawsuits and, therefore, decreased reporting. Some comments suggested 
that only events reportable to FDA be kept in FDA accessible files. 
Others suggested that confidential materials and irrelevant data be 
excluded from the files.
    FDA has addressed issues related to confidentiality of reports it 
receives in section IV.C., comment 24 of this document. As stated 
therein, certain statutory and regulatory protections exist that 
prevent release of confidential information. FDA does not agree that 
only events that are ultimately determined to be reportable should be 
kept in MDR files. FDA must be able to audit files containing events 
that were determined not reportable to ensure such determinations were 
correct.
    72. A few comments objected to FDA prescribing the method of record 
retention, preferring the use of individual systems.
    The agency disagrees. Effective and uniform regulatory enforcement 
is better assured by a standardized method of record retention. The 
agency believes that the method of record retention prescribed in this 
regulation does not impose an undue burden on the entities required to 
maintain such records.
    73. One comment suggested that separate files be kept for devices 
and patients.
    FDA does not object to a reporting entity maintaining separate 
files for devices and patients provided that all required information 
is contained in the MDR files.
    74. A few comments stated that a user facility should be required 
to keep files for a maximum of 2 years, rather than the expected life 
of the product, because some devices may have unusually long life 
expectancies.
    The agency agrees and has modified this section accordingly. It 
should be noted that device manufacturers, however, are still required 
to retain their records for 2 years or a period of time equivalent to 
the expected life of the device, whichever is greater.

M. Who Must Register and Submit a Device List (Section 807.20)

    75. One comment suggested that foreign manufacturers designate a 
U.S. agent to fulfill the registration and certification requirements. 
Another comment suggested that foreign manufacturers be permitted to 
register.
    Under Sec. 807.40 (21 CFR 807.40), foreign manufacturers are 
required to designate a U.S. agent to serve as an official 
correspondent, as well as to register and list their medical devices 
distributed in the United States, submit premarket notifications and 
ensure compliance with the MDR reporting requirements. In 
Sec. 807.40(a), FDA has changed the time allowed for foreign 
manufacturers to inform the agency of their designated U.S. agents, or 
a change in such agents, from 30 days to 5 days. FDA believes this is 
sufficient time to comply with this requirement.
    76. Under Sec. 807.20 (21 CFR 807.20), an owner or operator is 
required to register its ``name, places of business, and all 
establishments.'' Under this regulation, FDA has required the 
registration of all locations that fit within the definition of 
``establishment,'' which is defined under Sec. 807.3(a) (21 CFR 
807.3(a)) as a location where devices are ``manufactured, assembled, or 
otherwise processed.'' Although FDA has authority under Sec. 807.20 to 
require the registration of ``places of business'' that are not 
``establishments'' under initial registration and listing regulation 
that were issued in 1977, the agency previously has declined to 
exercise this authority.
    Under this regulation, FDA will use registration numbers in its 
data bases to process all manufacturer adverse event reports. Thus FDA 
must receive reports that originate from locations that may not be 
``establishments'' and, therefore, have previously not had registration 
numbers. Accordingly, FDA is notifying manufacturers that upon the 
effective date of this final regulation, the agency will exercise its 
authority under Sec. 807.20, and require all locations that are MDR 
reporting sites to register because they are ``places of business'' 
under Sec. 807.20, regardless of whether they fit under the definition 
of ``establishment.''

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, 

[[Page 63594]]
neither an environmental assessment nor an environmental impact 
statement is required.

VI. Intergovernmental Partnership

    The agency has analyzed this rulemaking in accordance with the 
principles and criteria set forth in the Unfunded Mandate Reform Act 
(Pub. L. 104-4) and Executive Order 12875. Executive Order 12875 states 
that no agency or executive department shall promulgate any regulation 
that is not required by statute and that creates a mandate upon a 
State, local, or tribal government unless the Federal government 
supplies funds necessary to comply with the mandate, or the agency 
provides the Office of Management and Budget (OMB) a description of the 
agency's consultations with affected State, local, and tribal 
governments, the nature of their concerns, any written communications 
submitted to the agency by such units of government, and the agency's 
position supporting the need to issue the regulation containing the 
mandate. Executive Order 12875 does not apply to this final rule 
because the regulatory requirements that are applicable to government 
facilities are required by the provisions of the SMDA, as amended by 
the 1992 amendments. Moreover, many of the comments the agency received 
in response to the November 26, 1991, tentative final rule were from 
Federal, State, or local government facilities or from organizations 
representing these facilities. The agency believes this final rule is 
responsive to those comments.
    The agency has also examined the consistency of this final rule 
with the Unfunded Mandate Reform Act. The Unfunded Mandate Reform Act 
requires (in section 202) that agencies prepare an assessment of 
anticipated costs and benefits before proposing any rule that may 
result in an annual expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million (adjusted annually for inflation). The Unfunded Mandate Reform 
Act does not apply to this final rule because it will not result in an 
annual expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector of $100 million.

VII. Analysis of Impacts

    FDA has examined the impact of the final rule under Executive Order 
12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the principles set out in the 
Executive Order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive Order.
    Many comments stated that the provisions of the rule, as proposed, 
are overly burdensome, that the costs outweigh the benefits, and that 
the economic impact was underestimated and misleading. Several comments 
stated that the provisions constitute too great a burden for FDA, as 
well as for user facilities, distributors, and manufacturers.
    The agency does not agree. For the reasons stated in the preamble, 
including section IV.A., comment 1 of this document, FDA believes this 
regulation carefully balances the interests of public health with 
industry requirements. The agency also does not agree that the economic 
impact assessment was misleading. The cost projections contained in the 
proposed rule were based upon the information available to the agency 
at the time.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    The full economic impact assessment is on file at the Dockets 
Management Branch (address above). This rule is designed to: (1) 
Implement provisions of the SMDA regarding user facility reporting to 
FDA of deaths and serious injuries and illnesses related to medical 
devices and (2) amend the MDR regulations that require manufacturers to 
report deaths, serious injuries and malfunctions related to medical 
devices to FDA.

A. Benefits

    The legislative history of the SMDA documents reports that device 
problems that occur in hospitals are rarely reported, despite full 
scale implementation of the current medical device reporting 
regulation. A 1986 Government Accounting Office report showed that less 
than 1 percent of device problems occurring in hospitals were reported 
directly to FDA. As a result, neither patients nor medical providers 
would have access to relevant safety information. This final rule 
requires user facilities to report device-related deaths and serious 
injuries promptly, and thus it expands the information base of FDA and 
the manufacturer for early detection of problems associated with 
medical devices. In addition to manufacturers, those required to report 
to FDA include device distributors, hospitals, nursing homes, 
ambulatory surgical facilities, and outpatient treatment and diagnostic 
facilities. As a result of this rule, FDA, patients, and medical 
providers will have access to relevant safety information not 
previously available. MDR reports alert FDA to life-threatening and 
other serious problems with medical devices that are on the market, and 
FDA then can address these problems through the appropriate mechanisms. 
Further, when the final rule is in place, FDA will begin to receive 
denominator, or baseline data, such as the number of a particular 
device manufactured, distributed, and in use in the previous year. This 
information will enable FDA to better perform trend analyses and 
determine the significance of a report or group of reports.
    Unfortunately, there are insufficient data available to quantify 
the benefits of the rule. The primary benefit of this rule is that it 
provides an early warning of device problems which is then evaluated 
together with other information and, if appropriate, followed by a 
corrective action such as the issuance of an FDA Safety Alert, recall, 
or other action. The agency believes the actions taken as a result of 
the information provided by MDR reports will provide benefits such as 
injuries prevented, lives saved, avoidance of hospitalization and 
outpatient treatment costs, and other possible benefits. Any 
quantification of benefits would require an estimation of both the 
number and seriousness of adverse events prevented by actions taken as 
the result of the evaluation of MDR reports. Thus the agency does not 
believe benefits can be quantified with any reliable accuracy.

B. Nature of the Economic Impact

    This regulation will require certain device user facilities to 
develop, maintain, and implement procedures for reporting deaths and 
serious injuries related to medical devices. Some current MDR 
requirements for manufacturers are being eliminated or reduced, but 
manufacturers will now be required to develop and maintain written MDR 
procedures and implement new reporting requirements, including the 
submission of baseline reports and annual updates and annual 
certification. In addition, foreign manufacturers will be required to 
designate an agent in the United States that will be responsible 

[[Page 63595]]
for submitting required documents for complying with the MDR reporting 
requirements and for related documentation.

C. Impact Assessment

    Based on the cost analysis, the economic impact on manufacturers, 
U.S. agents for foreign manufacturers, and users of medical devices 
will not exceed the $100 million threshold established under Executive 
Order 12866. Annualized one-time costs of about $9.1 million will be 
incurred by industry for establishing and/or documenting procedures for 
data collection and reporting. In addition, the annual cost of user 
reporting is estimated to be $31.7 million, for a total annualized 
industry cost of $40.8 million.
    An estimated 51,000 additional death and injury reports are 
expected as a result of adverse incidents that must be reported under 
this rule. This is in line with the Congressional Budget Office 
estimate of 40,000 reports. These incidents generate investigation, 
data analyses and summaries, and additional reporting requirements. 
Based on the above estimates, this translates to an average cost per 
adverse report of $799.
1. User Facility Costs
    Table 1 summarizes the total incremental initial and recurring 
costs of the reporting requirements for user facilities. These 
estimates are based on cost data from the Center for Devices and 
Radiological Health's draft report to Congress, entitled ``The 
Evaluation of Medical Device User Facility Reporting Requirements'', 
1994. Components of one-time costs include developing procedures and 
modifying forms for reporting and training personnel. The most 
significant one-time costs are $3.0 million for developing procedures 
and $2.6 million for ``other'' startup costs. The total annualized one-
time cost to user facilities is estimated to be $8.9 million.

                          Table 1.--Total Costs to User Facilities by Type of Facility                          
                                              [millions of dollars]                                             
----------------------------------------------------------------------------------------------------------------
                                                Number of     One-time                                          
                Facility type                   facilities      cost       Annualized      Annual       Total   
------------------------------------------------------------------------------\1\-------------------------------
Hospitals....................................        6,738          7.9           1.9           7.0          8.9
Nursing homes................................       25,648         12.7           3.1           5.3          8.4
Ambulatory surgical..........................        1,300          0.7           0.2           0.7          0.9
Outpatient diagnostic........................        7,578          3.3           0.8           0.7          1.5
Outpatient treatment.........................        4,041          2.5           0.6           1.4          2.0
Emergency medical service....................       15,600          9.5           2.3           4.1          6.4
                                              ------------------------------------------------------------------
      Total..................................       60,905         36.6           8.9          19.3        28.2 
----------------------------------------------------------------------------------------------------------------
\1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers may not add due to rounding.)             

    Annual costs include investigation of the event, reporting the 
event, preparing semiannual reports, and related computer, and other 
costs. The total annual cost to user facilities is $19.3 million. 
Hospitals and nursing homes incur about two- thirds of this cost at 
$7.0 million and $5.3 million, respectively. Major components of annual 
cost include $5.4 million to investigate and to prepare the initial 
reports. Semiannual reports are required only if a facility has a 
reportable event, and are estimated to cost $59,000. The most 
significant costs are for computer and other costs at $14.8 million. 
The total first-year costs to user facilities is $28.2 million.
2. Manufacturer and U.S. Agent for Foreign Manufacturer Costs
    Manufacturers are currently required under the current good 
manufacturing practices regulation to investigate complaints and 
analyze device failures. Manufacturers will now be required to document 
and maintain their MDR related procedures. The vast majority of 
manufacturers already have such written procedures in place. 
Incremental one-time costs for documenting these procedures will be 
$105 thousand. Foreign manufacturers will incur additional one-time 
costs of $662 thousand to select an agent and notify FDA. Annualized at 
7 percent over 5 years, this translates to $187 thousand per year.
    Manufacturers must also comply with the new reporting requirements. 
Table 2 presents the expected annual cost of reporting by type of 
facility and type of report. The major components of annual cost 
include the followup and reporting of additional adverse medical device 
events and the submission of baseline reports. MDR followup on user and 
distributor reports and completion of information on Form 3500A is 
expected to cost manufacturers $11.1 million annually for the estimated 
51,000 reports from user facilities and distributors. The cost of 8,000 
new baseline reports and 12,000 updates will be $598 thousand.

                                       Table 2.--Annual Cost of Reporting                                       
----------------------------------------------------------------------------------------------------------------
                                                                               Cost      Number of    Total cost
             Type of facility                       Type of report          (dollars)     reports       ($000)  
----------------------------------------------------------------------------------------------------------------
All manufacturers.........................  Followup MDR's from user/           217.60       51,000       11,098
                                             distributor facilities.                                            
                                            Baseline report..............        54.40        8,000          435
                                            Baseline update..............        13.60       12,000          163
                                            Five-day report..............       233.60          100           23
                                            Annual certification.........        26.00       12,145          316
Foreign only..............................  Fees for MDR reporting.......  ...........  ...........          134
                                            Fees for 510(k) filing.......       110.08          510           56
                                                                          --------------------------------------
      (All manufacturers-Total )..........  .............................  ...........  ...........       12,225
                                                                          ======================================
U.S. agents for foreign manufacturers.....  Register and list............        16.64        4,812           80

[[Page 63596]]
                                                                                                                
                                            Notify and document MDR's....         7.80        5,750           45
                                                                          --------------------------------------
      (U.S. agents for foreign              .............................  ...........  ...........          125
       manufacturers-Total).                                                                                    
                                                                          ======================================
      Total...............................  .............................  ...........  ...........       12,350
----------------------------------------------------------------------------------------------------------------



    In addition, domestic manufacturers and U.S. agents for foreign 
manufacturers will be required to certify annually the number of 
reportable events that have occurred. This is a formality in terms of 
data collection and reporting and is expected to cost $316 thousand. 
Foreign manufacturers will incur a fee of $190 thousand for reporting 
services conducted by their U.S. agents. Annual costs to U.S. agents 
are $125 thousand for registering and listing their foreign 
manufacturers establishments and products and for complying with 
reporting requirements. Previously, foreign manufacturers were required 
to submit premarket notifications or have their initial distributor in 
the United States do so. Now, U.S. agents will be required to submit 
premarket notifications for foreign manufacturers. This represents a 
transfer of existing requirements and therefore, no increase in cost.
3. Total Cost to Industry
    Table 3 presents a summary of the total annual costs to industry. 
Costs are $28.2 million for user facilities, $12.4 million for 
manufacturers, and $125 thousand for U.S. agents for foreign 
manufacturers, for a total annual cost to industry of $40.8 million.

               Table 3.--Total Annualized Cost to Industry              
                        [in millions of dollars]                        
------------------------------------------------------------------------
                                            One-time                    
                 Industry                      \1\     Annual     Total 
------------------------------------------------------------------------
User Facilities...........................      8.93     19.31     28.24
Manufacturers.............................      0.19     12.22     12.41
U.S. agents for foreign manufactuers......  ........      0.13      0.13
                                           -----------------------------
      Total...............................      9.12     31.66    40.77 
------------------------------------------------------------------------
\1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers   
  may not add due to rounding.)                                         

4. Small Business Impacts
    There is little likelihood that there will be a significant impact 
on small facilities. The one-time start-up costs range from $437 to 
$1,629 for user facilities, depending on facility type. Annualized at 7 
percent for 5 years, these costs range from $107 to $397 for user 
facilities. In addition, estimates of the annual number of additional 
medical device events attributable to this regulation are about 51,000. 
Because there are nearly 61,000 user facilities, this averages out to 
about .8 serious events per facility attributable to the user reporting 
rule at an annual cost of $400 per event.
    Similarly, small businesses in the medical device manufacturing 
industry will not be significantly affected, although the industry has 
a substantial number of small facilities, with about 65 percent of the 
establishments having fewer than 50 employees. No more than 22 percent 
of the anticipated $12 million annual impact of these regulations on 
manufacturers would be attributable to small establishments, or about 
$2.7 million per year. Because there are about 7,300 small medical 
device establishments (including foreign manufacturers), the average 
impact on one small establishment should be less than $338 annually. 
Assuming that all of the approximately 4,800 U.S. agents are small, on 
average, the $125 thousand impact on any one establishment would be $26 
annually.

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collections which are subject 
to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L. 
104-13). The title, description, and respondent description of the 
information collections are shown below and an estimate of the annual 
recordkeeping and periodic reporting burden. Included in the estimate 
is the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing the collection of information.
    Title: Reporting and recordkeeping requirements for user facilities 
and manufacturers of medical devices under the Safe Medical Devices Act 
of 1990 (SMDA) and the Medical Device Amendments of 1992 (1992 
Amendments)(General requirements).
    Description: This regulation implements provisions of the SMDA and 
the 1992 amendments regarding user facility reporting of deaths and 
serious injuries related to medical devices. This regulation also 
amends regulations regarding device manufacturer reporting of deaths, 
serious injuries, and certain malfunctions related to medical devices. 
The purpose of these changes is to improve the protection of the public 
health while also reducing the regulatory burden on reporting entities.
    Description of Respondents: Businesses or other for profit 
organizations, nonprofit organizations, Federal, State, and local 
governments.

                                 Table 4.--Estimated Annual Burden for Reporting                                
----------------------------------------------------------------------------------------------------------------
                                                               Number of                                        
                                                  Number of    responses      Total      Hours per              
                  CFR section                    respondents      per         annual      response   Total hours
                                                               respondent   responses                           
----------------------------------------------------------------------------------------------------------------
803.19.........................................          100          1.0          100          3.0         300 

[[Page 63597]]
                                                                                                                
803.30(a)......................................          700          1.0          700          3.0        2,100
803.30(b)......................................       20,000          1.5       30,000          3.0       90,000
803.33.........................................        2,000          1.0        2,000          1.0        2,000
803.50.........................................        1,250         40.0       50,000          0.5       25,000
803.53.........................................          100          1.0          100          0.5           50
803.55.........................................        1,000         20.0       20,000      \1\ 1.1       22,000
803.56.........................................          500         20.0       10,000          1.0       10,000
803.57.........................................       12,000          1.0       12,000          1.0       12,000
803.58.........................................        5,000          1.0        5,000          1.0        5,000
                                                ----------------------------------------------------------------
      Total....................................  ...........  ...........  ...........  ...........     168,450 
----------------------------------------------------------------------------------------------------------------
\1\ Although an initial submission will take an estimated 2 hours to complete, the annual update will take only 
  .5 hours. The average hours per response is therefore 1.1, as reflected here.                                 



           Table 5.--Estimated Annual Burden for Recordkeeping          
------------------------------------------------------------------------
                                  Number of      Hours per              
          CFR section           recordkeepers  recordkeeper  Total hours
------------------------------------------------------------------------
803.18(c).....................        36,639           0.25        9,160
803.18(e).....................           625          16.00       10,000
                               -----------------------------------------
      Total...................  .............  ............       19,160
------------------------------------------------------------------------

    Although the November 26, 1991, tentative final rule provided a 60-
day comment period (extended to 90 days in the January 24, 1992, 
Federal Register, 57 FR 2861), and this final rule is based on the 
comments received, FDA Form 3419 (semiannual report), FDA Form 3417 
(baseline report), and FDA Form 3381 (annual certification) have not 
been previously available to OMB or the public for review. Therefore, 
as required by section 3507(d) of the Paperwork Reduction Act of 1995, 
FDA has submitted a copy of this final rule to OMB for its review of 
these information collection requirements.
    In addition, the agency solicits public comment on the information 
collection requirements in order to: (1) Evaluate whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information will 
have practical utility; (2) evaluate the accuracy of the agency's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
enhance the quality, utility, and clarity of the information to be 
collected; and (4) minimize the burden of the collection of information 
on those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    Individuals and organizations may submit comments on the 
information collection requirements by January 10, 1996, and should 
direct them to FDA's Dockets Management Branch (address above) and to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., rm. 10235, 725 17th St. NW., Washington, DC 20503, 
Attention: Desk Officer for FDA.
    Persons are not required to respond to a collection of information 
unless it displays a currently valid OMB control number. This final 
rule contains information collection requirements which have been 
approved under OMB no. 0910-0059 and which expires on March 31, 1996. 
FDA will publish a notice in the Federal Register prior to the 
effective date of this final rule of OMB's decision to approve, modify 
or disapprove the information collection requirements.

List of Subjects

21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Medical devices, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, chapter 
I of title 21 of the Code of Federal Regulations is amended as follows:
    1. Part 803 is revised to read as follows:

PART 803--MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec.
803.1  Scope.
803.3  Definitions.
803.9  Public availability of reports.
803.10  General description of reports required from user facilities 
and manufacturers.
803.11  Obtaining the forms.
803.12  Where to submit reports.
803.13  English reporting requirement.
803.14  Electronic reporting.
803.15  Requests for additional information.
803.16  Disclaimers.
803.17  Written MDR procedures.
803.18  Files.
803.19  Exemptions, variances, and alternative reporting 
requirements.
Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports
803.20  How to report.
803.21  Reporting codes.
803.22  When not to file. 

[[Page 63598]]

Subpart C--User Facility Reporting Requirements
803.30  Individual adverse event reports; user facilities.
803.32  Individual adverse event report data elements.
803.33  Semiannual reports.

Subpart D--[Reserved]

Subpart E--Manufacturer Reporting Requirements
803.50  Individual adverse event reports; manufacturers.
803.52  Individual adverse event report data elements.
803.53  Five-day reports.
803.55  Baseline reports.
803.56  Supplemental reports.
803.57  Annual certification.
803.58  Foreign manufacturers.

    Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 
374).

Subpart A--General Provisions


Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device 
reporting. Under this part, device user facilities and manufacturers 
must report deaths and serious injuries to which a device has or may 
have caused or contributed, and must establish and maintain adverse 
event files. Manufacturers are also required to report certain device 
malfunctions and submit an annual report to FDA certifying that the 
correct number of medical device reports were filed during the previous 
12-month period or, alternatively, that no reports were required during 
that same time period. These reports will assist FDA in protecting the 
public health by helping to ensure that devices are not adulterated or 
misbranded and are safe and effective for their intended use.
    (b) This part supplements and does not supersede other provisions 
of this subchapter, including the provisions of part 820 of this 
chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to Chapter I of title 21, unless otherwise 
noted.


Sec. 803.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure or control of an entity). An ASF is subject to 
this regulation regardless of whether it is licensed by a Federal, 
State, municipal, or local government or regardless of whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the ASF must report that event 
regardless of the nature or location of the medical service provided by 
the ASF.
    (c) Become aware means that an employee of the entity required to 
report has acquired information reasonably suggesting a reportable 
adverse event has occurred. Device user facilities are considered to 
have ``become aware'' when medical personnel, as defined in paragraph 
(r) of this section, who are employed by or otherwise formally 
affiliated with the facility, acquire such information about a 
reportable event. Manufacturers are considered to have ``become aware'' 
of an event when:
    (1) Any employee becomes aware of a reportable event that is 
required to be reported within 30 days, or that is required to be 
reported within 5 days pursuant to a written request from FDA under 
803.53(b); and
    (2) Any employee, who is a person with management or supervisory 
responsibilities over persons with regulatory, scientific, or technical 
responsibilities, or a person whose duties relate to the collection and 
reporting of adverse events, becomes aware that a reportable MDR event 
or events, from any information, including any trend analysis, 
necessitate remedial action to prevent an unreasonable risk of 
substantial harm to the public health.
    (d) Caused or contributed means that a death or serious injury was 
or may have been attributed to a medical device, or that a medical 
device was or may have been a factor in a death or serious injury, 
including events occurring as a result of:
    (1) Failure;
    (2) Malfunction;
    (3) Improper or inadequate design;
    (4) Manufacture;
    (5) Labeling; or
    (6) User error.
    (e) (1) Device family means a group of one or more devices 
manufactured by or for the same manufacturer and having the same:
    (i) Basic design and performance characteristics related to device 
safety and effectiveness,
    (ii) Intended use and function, and
    (iii) Device classification and product code.
    (2) Devices that differ only in minor ways not related to safety or 
effectiveness can be considered to be in the same device family. 
Factors such as brand name and common name of the device and whether 
the devices were introduced into commercial distribution under the same 
510(k) or premarket approval application (PMA), may be considered in 
grouping products into device families.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in paragraphs (l), (b), (s), (t), and 
(u), respectively, of this section, which is not a ``physician's 
office,'' as defined in paragraph (w) of this section. School nurse 
offices and employee health units are not device user facilities.
    (g) [Reserved]
    (h) [Reserved]
    (i) Expected life of a device (required on the manufacturer's 
baseline report) means the time that a device is expected to remain 
functional after it is placed into use. Certain implanted devices have 
specified ``end of life'' (EOL) dates. Other devices are not labeled as 
to their respective EOL, but are expected to remain operational through 
maintenance, repair, upgrades, etc., for an estimated period of time.
    (j) FDA means the Food and Drug Administration.
    (k) Five-day report means a medical device report that must be 
submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form 
3500A or electronic equivalent as approved under Sec. 803.14, within 5 
work days.
    (l) Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (medical, occupational, 
speech, physical, etc.), surgical and other patient services for 
specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure or 
control of another entity). A hospital is covered by this regulation 
regardless of whether it is licensed by a Federal, State, municipal or 
local government or whether it is accredited by a recognized 
accreditation organization. If an adverse event meets the criteria for 
reporting, the hospital must report that event regardless of the nature 
or location of the medical service provided by the hospital.
    (m) Malfunction means the failure of a device to meet its 
performance specifications or otherwise perform as intended. 
Performance specifications include all claims made in the labeling for 
the device. The intended 

[[Page 63599]]
performance of a device refers to the intended use for which the device 
is labeled or marketed, as defined in Sec. 801.4 of this chapter.
    (n) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed 
and intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a 
particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    (o) Manufacturer report number means the number that uniquely 
identifies each individual adverse event report submitted by a 
manufacturer. This number consists of three parts as follows:
    (1) The FDA registration number for the manufacturing site of the 
reported device. (If the manufacturing site does not have a 
registration number, FDA will assign a temporary number until the site 
is officially registered. The manufacturer will be informed of the 
temporary number.);
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear 1234567-1995-00001.)
    (p) MDR means medical device report.
    (q) MDR reportable event (or reportable event) means:
    (1) An event about which user facilities become aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to a death or serious injury; or
    (2) An event about which manufacturers have received or become 
aware of information that reasonably suggests that one of their 
marketed devices:
    (i) May have caused or contributed to a death or serious injury; or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer would be likely to cause or contribute to 
a death or serious injury if the malfunction were to recur.
    (r) Medical personnel, as used in this part, means an individual 
who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of such persons.
    (s)(1) Nursing home means an independent entity (i.e., not a part 
of a provider of services or any other facility) or one operated by 
another medical entity (e.g., under the common ownership, licensure, or 
control of an entity) that operates for the primary purpose of 
providing:
    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.
    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature, or 
location of the medical service provided by the nursing home.
    (t)(1) Outpatient diagnostic facility means a distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients;
    (ii) Does not assume ongoing responsibility for patient care; and
    (iii) Provides its services for use by other medical personnel. 
(Examples include diagnostic radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography and in-vitro testing).
    (2) An outpatient diagnostic facility may be either independent 
(i.e., not a part of a provider of services or any other facility) or 
operated by another medical entity (e.g., under the common ownership, 
licensure, or control of an entity). An outpatient diagnostic facility 
is covered by this regulation regardless of whether it is licensed by a 
Federal, State, municipal, or local government or whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the outpatient diagnostic 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient diagnostic facility.
    (u) (1) Outpatient treatment facility means a distinct entity that 
operates for the primary purpose of providing nonsurgical therapeutic 
(medical, occupational, or physical) care on an outpatient basis or 
home health care setting. Outpatient treatment facilities include 
ambulance providers, rescue services, and home health care groups. 
Examples of services provided by outpatient treatment facilities 
include: Cardiac defibrillation, chemotherapy, radiotherapy, pain 
control, dialysis, speech or physical therapy, and treatment for 
substance abuse.
    (2) An outpatient treatment facility may be either independent 
(i.e., not a part of a provider of services or any other facility) or 
operated by another medical entity (e.g., under the common ownership, 
licensure, or control of an entity). An outpatient treatment facility 
is covered by this regulation regardless of whether it is licensed by a 
Federal, State, municipal, or local government or whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the outpatient treatment 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient treatment facility.
    (v) Patient of the facility means any individual who is being 
diagnosed or treated and/or receiving medical care at or under the 
control or authority of the facility. For the purposes of this part, 
the definition encompasses employees of the facility or individuals 
affiliated with the facility, who in the course of their duties suffer 
a device-related death or serious injury that has or may have been 
caused or contributed to by a device used at the facility.
    (w) Physician's office means a facility that operates as the office 
of a physician or other health care professional (e.g., dentist, 
chiropractor, optometrist, nurse practitioner, school nurse offices, 
school clinics, employee health clinics, or free-standing care units) 
for the primary purpose of examination, evaluation, and treatment or 
referral of patients. A physician's office may be independent, a group 
practice, or part of a Health Maintenance Organization.
    (x) [Reserved]
    (y) Remedial action means, for the purposes of this subpart, any 
action other than routine maintenance or servicing, of a device where 
such action is necessary to prevent recurrence of a reportable event.
    (z) [Reserved]
    (aa)(1) Serious injury means an injury or illness that: 
    
[[Page 63600]]

    (i) Is life-threatening;
    (ii) Results in permanent impairment of a body function or 
permanent damage to body structure; or
    (iii) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure.
    (2) Permanent means, for purposes of this subpart, irreversible 
impairment or damage to a body structure or function, excluding trivial 
impairment or damage.
    (bb) Shelf life, as required on the manufacturer's baseline report, 
means the maximum time a device will remain functional from the date of 
manufacture until it is used in patient care. Some devices have an 
expiration date on their labeling indicating the maximum time they can 
be stored before losing their ability to perform their intended 
function.
    (cc) [Reserved]
    (dd)(1) User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers 
and FDA. This number consists of three parts as follows:
    (i) The user facility's 10-digit Health Care Financing 
Administration (HCFA) number (if the HCFA number has fewer than 10 
digits, fill the remaining spaces with zeros);
    (ii) The four-digit calendar year in which the report is submitted; 
and
    (iii) The four-digit sequence number of the reports submitted for 
the year, starting with 0001. (For example, a complete number will 
appear as follows: 1234560000-1995-0001.)
    (2) If a facility has more than one HCFA number, it must select one 
that will be used for all of its MDR reports. If a facility has no HCFA 
number, it should use all zeros in the appropriate space in its initial 
report (e.g., 0000000000-1995-0001) and FDA will assign a number for 
future use. The number assigned will be used in FDA's record of that 
report and in any correspondence with the user facility. All zeros 
should be used subsequent to the first report if the user does not 
receive FDA's assigned number before the next report is submitted. If a 
facility has multiple sites, the primary site can report centrally and 
use one reporting number for all sites if the primary site provides the 
name, address and HCFA number for each respective site.
    (ee) Work day means Monday through Friday, excluding Federal 
holidays.


Sec. 803.9  Public availability of reports.

    (a) Any report, including any FDA record of a telephone report, 
submitted under this part is available for public disclosure in 
accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter;
    (2) Any personal, medical, and similar information (including the 
serial number of implanted devices), which would constitute an invasion 
of personal privacy under Sec. 20.63 of this chapter. FDA will disclose 
to a patient who requests a report, all the information in the report 
concerning that patient, as provided in Sec. 20.61 of this chapter; and
    (3) Any names and other identifying information of a third party 
voluntarily submitting an adverse event report.
    (c) FDA may not disclose the identity of a device user facility 
which makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the act, 
including the failure or refusal to furnish material or information 
required by section 519 of the act;
    (2) A communication to a manufacturer of a device which is the 
subject of a report required by a user facility under Sec. 803.30;
    (3) A disclosure relating to a manufacturer or distributor adverse 
event report that is required under section 519(a) of the act; or
    (4) A disclosure to employees of the Department of Health and Human 
Services, to the Department of Justice, or to the duly authorized 
committees and subcommittees of the Congress.


Sec. 803.10  General description of reports required from user 
facilities and manufacturers.

    (a) Device user facilities. User facilities must submit the 
following reports, which are described more fully in subpart C of this 
part.
    (1) User facilities must submit MDR reports of individual adverse 
events within 10 days after the user facility becomes aware of an MDR 
reportable event as described in Secs. 803.30 and 803.32.
    (i) User facilities must submit reports of device-related deaths to 
FDA and to the manufacturer, if known.
    (ii) User facilities must submit reports of device-related serious 
injuries to manufacturers, or to FDA, if the manufacturer is unknown.
    (2) User facilities must submit semiannual reports as described in 
Sec. 803.33.
    (b) [Reserved]
    (c) Device manufacturers. Manufacturers must submit the following 
reports as described more fully in subpart E of this part:
    (1) MDR reports of individual adverse events within 30 days after 
the manufacturer becomes aware of a reportable death, serious injury, 
or malfunction as described in Secs. 803.50 and 803.52.
    (2) MDR reports of individual adverse events within 5 days of:
    (i) Becoming aware that a reportable MDR event requires remedial 
action to prevent an unreasonable risk of substantial harm to the 
public health or,
    (ii) Becoming aware of an MDR reportable event for which FDA has 
made a written request, as described in Sec. 803.53.
    (3) Annual baseline reports as described in Sec. 803.55.
    (4) Supplemental reports if they obtain information that was not 
provided in an initial report as described in Sec. 803.56.
    (5) Annual certification to FDA of the number of MDR reports filed 
during the preceding year as described in Sec. 803.57.


Sec. 803.11  Obtaining the forms.

    User facilities and manufacturers must submit all reports of 
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an 
electronic equivalent as approved under Sec. 803.14. This form and all 
other forms referenced in this section can also be obtained from the 
Consolidated Forms and Publications Office, Washington Commerce Center, 
3222 Hubbard Rd., Landover, MD 20785, or from the Division of Small 
Manufacturers Assistance, Office of Health and Industry Programs, 
Center for Devices and Radiological Health, 1350 Piccard Dr. (HFZ-220), 
Rockville, MD 20850, telephone facsimile (FAX) 301-443-8818. FDA Form 
3500A may also be obtained from the Food and Drug Administration, 
MEDWATCH (HF-2), 5600 Fishers Lane, rm. 9-57, Rockville, MD 20850, 301-
443-0117.


Sec. 803.12  Where to submit reports.

    (a) Any written report or additional information required under 
this part shall be submitted to: Food and Drug Administration, Center 
for Devices and Radiological Health, Medical Device Reporting, PO Box 
3002, Rockville, MD 20847-3002.
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``SemiAnnual Report,'' ``Manufacturer 
Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
    (c) If an entity is confronted with a public health emergency, this 
can be brought to FDA's attention by contacting the FDA Emergency 
Operations Branch 

[[Page 63601]]
(HFC-162), Office of Regional Operations, at 301-443-1240, and should 
be followed by the submission of a FAX report to 301-443-3757.
    (d) A voluntary telephone report may be submitted to, or 
information regarding voluntary reporting may be obtained from, the 
MEDWATCH hotline at 800-FDA-1088.


Sec. 803.13  English reporting requirement.

    (a) All reports required in this part which are submitted in 
writing or electronic equivalent shall be submitted to FDA in English.
    (b) All reports required in this part which are submitted on an 
electronic medium shall be submitted to FDA in a manner consistent with 
Sec. 803.14.


Sec. 803.14  Electronic reporting.

    (a) Any report required by this part may be submitted 
electronically with prior written consent from FDA. Such consent is 
revocable. Electronic report submissions include alternative reporting 
media (magnetic tape, disc, etc.) and computer-to-computer 
communication.
    (b) Any electronic report meeting electronic reporting standards, 
guidelines, or other procedures developed by the agency for MDR 
reporting will be deemed to have prior approval for use.


Sec. 803.15  Requests for additional information.

    (a) FDA may determine that protection of the public health requires 
additional or clarifying information for medical device reports 
submitted to FDA under this part. In these instances, and in cases when 
the additional information is beyond the scope of FDA reporting forms 
or is not readily accessible, the agency will notify the reporting 
entity in writing of the additional information that is required.
    (b) Any request under this section shall state the reason or 
purpose for which the information is being requested, specify the date 
that the information is to be submitted and clearly relate the request 
to a reported event. All verbal requests will be confirmed in writing 
by the agency.


Sec. 803.16  Disclaimers.

    A report or other information submitted by a reporting entity under 
this part, and any release by FDA of that report or information, does 
not necessarily reflect a conclusion by the party submitting the report 
or by FDA that the report or information constitutes an admission that 
the device, or the reporting entity or its employees, caused or 
contributed to the reportable event. The reporting entity need not 
admit and may deny that the report or information submitted under this 
part constitutes an admission that the device, the party submitting the 
report, or employees thereof, caused or contributed to a reportable 
event.


Sec. 803.17  Written MDR procedures.

    User facilities and manufacturers shall develop, maintain, and 
implement written MDR procedures for the following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to medical device reporting 
requirements;
    (2) A standardized review process/procedure for determining when an 
event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to FDA 
and/or manufacturers;
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;
    (2) All medical device reports and information submitted to FDA and 
manufacturers;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of semiannual reports or certification; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by FDA.


Sec. 803.18  Files.

    (a) User facilities and manufacturers shall establish and maintain 
MDR event files. All MDR event files shall be prominently identified as 
such and filed to facilitate timely access.
    (b) (1) For purposes of this part, ``MDR event files'' are written 
or electronic files maintained by user facilities and manufacturers. 
MDR event files may incorporate references to other information, e.g., 
medical records, patient files, engineering reports, etc., in lieu of 
copying and maintaining duplicates in this file. MDR event files must 
contain:
    (i) Information in the possession of the reporting entity or 
references to information related to the adverse event, including all 
documentation of the entity's deliberations and decisionmaking 
processes used to determine if a device-related death, serious injury, 
or malfunction was or was not reportable under this part.
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., a distributor or manufacturer).
    (2) User facilities and manufacturers shall permit any authorized 
FDA employee during all reasonable times to access, to copy, and to 
verify the records required by this part.
    (c) User facilities shall retain an MDR event file relating to an 
adverse event for a period of 2 years from the date of the event. 
Manufacturers shall retain an MDR event file relating to an adverse 
event for a period of 2 years from the date of the event or a period of 
time equivalent to the expected life of the device, whichever is 
greater. MDR event files must be maintained for the time periods 
described in this paragraph even if the device is no longer 
distributed.
    (d) [Reserved]
    (e) The manufacturer may maintain MDR event files as part of its 
complaint file, under Sec. 820.198 of this chapter, provided that such 
records are prominently identified as MDR reportable events. A report 
submitted under this subpart A shall not be considered to comply with 
this part unless the event has been evaluated in accordance with the 
requirements of Secs. 820.162 and 820.198 of this chapter. MDR files 
shall contain an explanation of why any information required by this 
part was not submitted or could not be obtained. The results of the 
evaluation of each event are to be documented and maintained in the 
manufacturer's MDR event file.


Sec. 803.19  Exemptions, variances, and alternative reporting 
requirements.

    (a) The following persons are exempt from the reporting 
requirements under this part.
    (1) An individual who is a licensed practitioner who prescribes or 
administers devices intended for use in humans and who manufactures or 
imports devices solely for use in diagnosing and treating persons with 
whom the practitioner has a ``physician- patient'' relationship.
    (2) An individual who manufactures devices intended for use in 
humans solely for such person's use in research or teaching and not for 
sale, including any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations, 
parts 812 and 813 of this chapter, which require reporting of all 
adverse device effects.
    (3) Dental laboratories, or optical laboratories.
    (b) Manufacturers or user facilities may request exemptions or 
variances from any or all of the reporting requirements in this part. 
The request shall be in writing and include information necessary to 
identify the 

[[Page 63602]]
firm and device, a complete statement of the request for exemption, 
variance, or alternative reporting, and an explanation why the request 
is justified.
    (c) FDA may grant in writing, to a manufacturer or user facility, 
an exemption, variance or alternative from, or to, any or all of the 
reporting requirements in this part and may change the frequency of 
reporting to quarterly, semiannually, annually, or other appropriate 
time period. These modifications may be initiated by a request as 
specified in this section, or at the discretion of FDA. When granting 
such modifications, FDA may impose other reporting requirements to 
ensure the protection of public health.
    (d) FDA may revoke or modify in writing an exemption, variance, or 
alternative reporting requirements if FDA determines that protection of 
the public health justifies the modification or a return to the 
requirements as stated in this part.
    (e) Firms granted a reporting modification by FDA shall provide any 
reports or information required by that approval. The conditions of the 
approval will replace and supersede the reporting requirement specified 
in this part until such time that FDA revokes or modifies the 
alternative reporting requirements in accordance with paragraph (d) of 
this section.

Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports


Sec. 803.20  How to report.

     (a) Description of form. There are two versions of the MEDWATCH 
form for individual reports of adverse events. FDA Form 3500 is 
available for use by health professionals and consumers for the 
submission of voluntary reports regarding FDA-regulated products. FDA 
Form 3500A is the mandatory reporting form to be used for submitting 
reports by user facilities and manufacturers of FDA-regulated products. 
The form has sections that must be completed by all reporters and other 
sections that must be completed only by the user facility or 
manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device and ``initial reporter'' (i.e., the 
first person or entity that submitted the information to the user 
facility, manufacturer, or distributor).
    (2) The back part of the form contains sections to be completed by 
user facilities and manufacturers. User facilities must complete 
section F; device manufacturers must complete sections G and H. 
Manufacturers are not required to recopy information submitted to them 
on a Form 3500A unless the information is being copied onto an 
electronic medium. If the manufacturer corrects or supplies information 
missing from the other reporter's 3500A form, it should attach a copy 
of that form to the manufacturer's report form. If the information from 
the other reporter's 3500A form is complete and correct, the 
manufacturer can fill in the remaining information on the same form.
    (b) Reporting standards. (1) User facilities are required to submit 
MDR reports to:
    (i) The device manufacturer and to FDA within 10 days of becoming 
aware of information that reasonably suggests that a device has or may 
have caused or contributed to a death; or
    (ii) The manufacturer within 10 days of becoming aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to a serious injury. Such reports shall be 
submitted to FDA if the device manufacturer is not known.
    (2) [Reserved]
    (3) Manufacturers are required to submit MDR reports to FDA:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device may have caused or contributed to a death or 
serious injury; or
    (ii) Within 30 days of becoming aware of information that 
reasonably suggests a device has malfunctioned and that device or a 
similar device marketed by the manufacturer would be likely to cause a 
death or serious injury if the malfunction were to recur; or
    (iii) Within 5 days if required by Sec. 803.53.
    (c) Information that reasonably suggests a reportable event 
occurred (1) Information that reasonably suggests that a device has or 
may have caused or contributed to an MDR reportable event (i.e., death, 
serious injury, and, for manufacturers, a malfunction that would be 
likely to cause or contribute to a death or serious injury if the 
malfunction were to recur) includes any information, such as 
professional, scientific or medical facts and observations or opinions, 
that would reasonably suggest that a device has caused or may have 
caused or contributed to a reportable event.
     (2) Entities required to report under this part do not have to 
report adverse events for which there is information that would cause a 
person who is qualified to make a medical judgment (e.g., a physician, 
nurse, risk manager, or biomedical engineer) to reach a reasonable 
conclusion that a device did not cause or contribute to a death or 
serious injury, or that a malfunction would not be likely to cause or 
contribute to a death or serious injury if it were to recur. 
Information which leads the qualified person to determine that a 
device-related event is or is not reportable must be contained in the 
MDR event files, as described in Sec. 803.18.


Sec. 803.21  Reporting codes.

    (a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding 
Manual for use with medical device reports. This manual contains codes 
for hundreds of adverse events for use with FDA Form 3500A. The coding 
manual is available from the Division of Small Manufacturer Assistance, 
Center for Devices and Radiological Health, 1350 Piccard Dr., 
Rockville, MD 20850, FAX 301-443-8818.
    (b) FDA may use additional coding of information on the reporting 
forms or modify the existing codes on an ad hoc or generic basis. In 
such cases, FDA will ensure that the new coding information is 
available to all reporters.


Sec. 803.22  When not to file.

     (a) Only one medical device report from the user facility or 
manufacturer is required under this part if the reporting entity 
becomes aware of information from multiple sources regarding the same 
patient and same event.
    (b) A medical device report that would otherwise be required under 
this section is not required if:
    (1) The user facility or manufacturer determines that the 
information received is erroneous in that a device-related adverse 
event did not occur. Documentation of such reports shall be retained in 
MDR files for time periods specified in Sec. 803.18.
    (2) The manufacturer determines that the device was manufactured by 
another manufacturer. Any reportable event information that is 
erroneously sent to a manufacturer shall be forwarded to FDA, with a 
cover letter explaining that the device in question was not 
manufactured by that firm.

 Subpart C--User Facility Reporting Requirements


Sec. 803.30  Individual adverse event reports; user facilities.

     (a) Reporting standard. A user facility shall submit the following 
reports to the manufacturer or to FDA, or both, as specified below:
     (1) Reports of death. Whenever a user facility receives or 
otherwise becomes aware of information, from any source, that 
reasonably suggests that a device 

[[Page 63603]]
has or may have caused or contributed to the death of a patient of the 
facility, the facility shall as soon as practicable, but not later than 
10 work days after becoming aware of the information, report the 
information required by Sec. 803.32 to FDA, on FDA Form 3500A, or an 
electronic equivalent as approved under Sec. 803.14, and if the 
identity of the manufacturer is known, to the device manufacturer.
     (2) Reports of serious injury. Whenever a user facility receives 
or otherwise becomes aware of information, from any source, that 
reasonably suggests that a device has or may have caused or contributed 
to a serious injury to a patient of the facility, the facility shall, 
as soon as practicable but not later than 10 work days after becoming 
aware of the information, report the information required by 
Sec. 803.32, on FDA Form 3500A or electronic equivalent, as approved 
under Sec. 803.14, to the manufacturer of the device. If the identity 
of the manufacturer is not known, the report shall be submitted to FDA.
    (b) Information that is reasonably known to user facilities. User 
facilities must provide all information required in this subpart C that 
is reasonably known to them. Such information includes information 
found in documents in the possession of the user facility and any 
information that becomes available as a result of reasonable followup 
within the facility. A user facility is not required to evaluate or 
investigate the event by obtaining or evaluating information that is 
not reasonably known to it.


Sec. 803.32  Individual adverse event report data elements.

     User facility reports shall contain the following information, 
reasonably known to them as described in 803.30(b), which corresponds 
to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
     (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of event or problem, including a discussion of how 
the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests including dates and laboratory 
data; and
    (7) Description of other relevant history including pre- existing 
medical conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether device was available for evaluation and whether device 
was returned to the manufacturer; if so, the date it was returned to 
the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the user facility, manufacturer, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether initial reporter also sent a copy of the report to FDA, 
if known.
    (e) User facility information (Block F) shall contain the 
following:
    (1) Whether reporter is a user facility;
    (2) User facility number;
    (3) User facility address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the user facility became aware of the event (month, day, 
year);
    (7) Type of report (initial or followup (if followup, include 
report number of initial report));
    (8) Date of the user facility report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
FDA ``Coding Manual For Form 3500A'');
    (11) Whether a report was sent to FDA and the date it was sent 
(month, day, year);
    (12) Location, where event occurred;
    (13) Whether report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address; if available.


Sec. 803.33  Semiannual reports.

    (a) Each user facility shall submit to FDA a semiannual report on 
FDA Form 3419, or electronic equivalent as approved by FDA under 
Sec. 803.14. Semiannual reports shall be submitted by January 1 (for 
reports made July through December) and by July 1 (for reports made 
January through June) of each year. The semiannual report and envelope 
shall be clearly identified and submitted to FDA with information that 
includes:
    (1) User facility's HCFA provider number used for medical device 
reports, or number assigned by FDA for reporting purposes in accordance 
with Sec. 803.3(dd);
    (2) Reporting year and period, e.g., January through June or July 
through December;
    (3) Facility's name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the semiannual report and the lowest and highest user 
facility report number of medical device reports submitted during the 
report period, e.g., 1234567890-1995-0001 through 1000;
    (6) Name, position title, and complete address of the individual 
designated as the facility contact person responsible for reporting to 
FDA and whether that person is a new contact for that facility; and
    (7) Information for each reportable event that occurred during the 
semiannual reporting period including:
    (i) User facility report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer 
and/or FDA; and
    (vi) Where the report was submitted, i.e., to FDA, manufacturer, 
distributor, etc.
    (b) In lieu of submitting the information in paragraph (a)(7) of 
this section, a user facility may submit a copy of FDA Form 3500A, or 
an electronic equivalent as approved under section 803.14, for each 
medical device report submitted to FDA and/or 

[[Page 63604]]
manufacturers by that facility during the reporting period.
    (c) If no reports are submitted to either FDA or manufacturers 
during these time periods, no semiannual report is required.

Subpart D--[Reserved]

Subpart E--Manufacturer Reporting Requirements


Sec. 803.50  Individual adverse event reports; manufacturers.

    (a) Reporting standards. Device manufacturers are required to 
report within 30 days whenever the manufacturer receives or otherwise 
becomes aware of information, from any source, that reasonably suggests 
that a device marketed by the manufacturer:
    (1) May have caused or contributed to a death or serious injury; or
    (2) Has malfunctioned and such device or similar device marketed by 
the manufacturer would be likely to cause or contribute to a death or 
serious injury, if the malfunction were to recur.
    (b) Information that is reasonably known to manufacturers.--(1) 
Manufacturers must provide all information required in this subpart E 
that is reasonably known to them. FDA considers the following 
information to be reasonably known to the manufacturer:
    (i) Any information that can be obtained by contacting a user 
facility, distributor and/or other initial reporter;
    (ii) Any information in a manufacturer's possession; or
    (iii) Any information that can be obtained by analysis, testing or 
other evaluation of the device.
    (2) Manufacturers are responsible for obtaining and providing FDA 
with information that is incomplete or missing from reports submitted 
by user facilities, distributors, and other initial reporters. 
Manufacturers are also responsible for conducting an investigation of 
each event, and evaluating the cause of the event. If a manufacturer 
cannot provide complete information on an MDR report, it must provide a 
statement explaining why such information was incomplete and the steps 
taken to obtain the information. Any required information not available 
at the time of the report, which is obtained after the initial filing, 
must be provided by the manufacturer in a supplemental report under 
Sec. 803.56.


Sec. 803.52  Individual adverse event report data elements.

    Individual medical device manufacturer reports shall contain the 
following information, known or reasonably known to them as described 
in Sec. 803.50(b), which corresponds to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including pre-existing medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
FDA, if known.
    (e) All manufacturers (Block G) shall contain the following:
    (1) Contact office name and address and device manufacturing site;
    (2) Telephone number;
    (3) Report sources;
    (4) Date received by manufacturer (month, day, year);
    (5) Type of report being submitted (e.g., 5-day, initial, 
supplemental); and
    (6) Manufacturer report number.
    (f) Device manufacturers (Block H) shall contain the following:
    (1) Type of reportable event (death, serious injury, malfunction, 
etc.);
    (2) Type of followup report, if applicable (e.g., correction, 
response to FDA request, etc.);
    (3) If the device was returned to the manufacturer and evaluated by 
the manufacturer, a summary of the evaluation. If no evaluation was 
performed, provide an explanation why no evaluation was performed;
    (4) Device manufacture date (month, day, year);
    (5) Was device labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA ``Coding Manual for Form 
3500A'');
    (7) Whether remedial action was taken and type;
    (8) Whether use of device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the act (list the correction/removal report 
number); and
    (10) Additional manufacturer narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or 
distributor report, including missing event codes, or information 
corrected on such forms after manufacturer verification;
    (ii) For each event code provided by the user facility under 
Sec. 803.32(d)(10) or a distributor, a statement of whether the type of 
the event represented by the code is addressed in the device labeling; 
and
    (iii) If any required information was not provided, an explanation 
of why such information was not provided and the steps taken to obtain 
such information.


Sec. 803.53  Five-day reports.

    A manufacturer shall submit a 5-day report to FDA, on Form 3500A or 
electronic equivalent as approved by FDA under Sec. 803.14 within 5 
workdays of: 

[[Page 63605]]

    (a) Becoming aware that a reportable MDR event or events, from any 
information, including any trend analysis, necessitates remedial action 
to prevent an unreasonable risk of substantial harm to the public 
health; or
    (b) Becoming aware of an MDR reportable event for which FDA has 
made a written request for the submission of a 5-day report. When such 
a request is made, the manufacturer shall submit, without further 
requests, a 5-day report for all subsequent events of the same nature 
that involve substantially similar devices for the time period 
specified in the written request. The time period stated in the 
original written request can be extended by FDA if it is in the 
interest of the public health.


Sec. 803.55  Baseline reports.

    (a) A manufacturer shall submit a baseline report on FDA Form 3417, 
or electronic equivalent as approved by FDA under Sec. 803.14 for a 
device when the device model is first reported under Sec. 803.50.
    (b) Each baseline report shall be updated annually, on the 
anniversary month of the initial submission, after the initial baseline 
report is submitted. Changes to baseline information shall be reported 
in the manner described in Sec. 803.56 (i.e., include only the new, 
changed, or corrected information in the appropriate portion(s) of the 
report form). Baseline reports shall contain the following:
    (1) Name, complete address, and registration number of the 
manufacturer's reporting site. If the reporting site is not registered, 
FDA will assign a temporary registration number until the reporting 
site officially registers. The manufacturer will be informed of the 
temporary registration number;
    (2) FDA registration number of each site where the device is 
manufactured;
    (3) Name, complete address, and telephone number of the individual 
who has been designated by the manufacturer as its MDR contact and date 
of the report. For foreign manufacturers, a confirmation that the 
individual submitting the report is the agent of the manufacturer 
designated under Sec. 803.58(a) is required;
    (4) Product identification, including device family, brand name, 
generic name, model number, catalog number, product code and any other 
product identification number or designation;
    (5) Identification of any device previously reported in a baseline 
report that is substantially similar (e.g., same device with a 
different model number, or same device except for cosmetic differences 
in color or shape) to the device being reported, including the 
identification of the previously reported device by model number, 
catalog number or other product identification, and the date of the 
baseline report for the previously reported device;
    (6) Basis for marketing, including 510(k) premarket notification 
number or PMA number, if applicable, and whether the device is 
currently the subject of an approved post-market study under section 
522 of the act;
    (7) Date the device was initially marketed and, if applicable, the 
date on which the manufacturer ceased marketing the device;
    (8) Shelf life, if applicable, and expected life of the device;
    (9) The number of devices manufactured and distributed in the last 
12 months and, an estimate of the number of devices in current use; and
    (10) Brief description of any methods used to estimate the number 
of devices distributed and the method used to estimate the number of 
devices in current use. If this information was provided in a previous 
baseline report, in lieu of resubmitting the information, it may be 
referenced by providing the date and product identification for the 
previous baseline report.


Sec. 803.56  Supplemental reports.

    When a manufacturer obtains information required under this part 
that was not provided because it was not known or was not available 
when the initial report was submitted, the manufacturer shall submit to 
FDA the supplemental information within 1 month following receipt of 
such information. In supplemental reports, the manufacturer shall:
    (a) Indicate on the form and the envelope, that the reporting form 
being submitted is a supplemental report. If the report being 
supplemented is an FDA Form 3500A report, the manufacturer must select, 
in Item H-2, the appropriate code for the type of supplemental 
information being submitted;
    (b) Provide the appropriate identification numbers of the report 
that will be updated with the supplemental information, e.g., original 
manufacturer report number and user facility report number, if 
applicable;
    (c) For reports that cross reference previous reports, include only 
the new, changed, or corrected information in the appropriate 
portion(s) of the respective form(s).


Sec. 803.57  Annual certification.

    All manufacturers, including U.S. agents of foreign manufacturers 
required to report under this section, shall submit a certification 
report to FDA, on FDA Form 3381, or electronic equivalent as approved 
under part 814 of this chapter. The date for submission of 
certification coincides with the date for the firm's annual 
registration, as designated in Sec. 807.21 of this chapter. The 
certification period will be the 12-month period ending 1 month before 
the certification date. The reports shall contain the following 
information:
    (a) Name, address, telephone number, and FDA registration number or 
FDA-assigned identification number of the firm and whether the firm is 
a manufacturer;
    (b) A statement certifying that:
    (1) The firm listed in paragraph (a) of this section has filed 
reports for all reportable events required under this section during 
the previous 12-month period. The firm shall also provide a numerical 
summary of MDR reports that it submitted to FDA during the preceding 
year; or
    (2) The firm listed in paragraph (a) of this section did not 
receive reportable events for any devices manufactured by the firm 
during the previous 12-month period.
    (c) Certification shall be made by the president, chief executive 
officer, U.S.-designated agent of a foreign manufacturer, or other 
official most directly responsible for the firm's operations; and
    (d) Name of the manufacturer and registration numbers submitted 
under paragraph (a) of this section shall be the same as those used in 
submitting the reports required by Secs. 803.52, 803.53 and 803.55. 
Multisite manufacturers who choose to certify centrally must identify 
the reporting sites, by registration number or FDA-assigned 
identification number and name covered by the certification, and 
provide the information required by paragraph (b) of this section for 
each reporting site.


Sec. 803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec. 807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, 
foreign manufacturers shall inform FDA, by letter, of the name and 
address of the U.S. agent designated under this section and Sec. 807.40 
of this chapter, and shall update this information as necessary. Such 
updated information shall be submitted to FDA, within 5 days of a 
change in the designated agent information. 

[[Page 63606]]

    (b) U.S.-designated agents of foreign manufacturers are required 
to:
    (1) Report to FDA in accordance with Secs. 803.50, 803.52, 803.53, 
803.55, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec. 803.50;
    (3) Certify in accordance with Sec. 803.57;
    (4) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (5) Maintain complaint files in accordance with Sec. 803.18; and
    (6) Register, list, and submit premarket notifications in 
accordance with part 807 of this chapter.

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND DISTRIBUTORS OF DEVICES

    2. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: Secs. 301, 501, 502, 510, 513, 515, 519, 520, 701, 
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 
352, 360, 360c, 360e, 360i, 360j, 371, 374).

    3. Section 807.3 is amended by adding new paragraph (r) to read as 
follows:


Sec. 807.3  Definitions.

* * * * *
    (r) U.S.-designated agent means the person, residing in the United 
States, designated and authorized by the owner or operator of a foreign 
manufacturer who exports devices into the United States and is 
responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,
    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications on behalf of the foreign 
manufacturer.
    4. Section 807.20 is amended by adding new paragraph (a)(6) to read 
as follows:


Sec. 807.20  Who must register and submit a device list.

    (a) * * *
    (6) Acts as the U.S.-designated agent as defined in Sec. 807.3(r).
* * * * *
    5. Section 807.22 is amended by revising paragraph (a) to read as 
follows:


Sec. 807.22  How and where to register establishments and list devices.

    (a) The first registration of a device establishment shall be on 
Form FDA-2891 (Initial Registration of Device Establishment). Forms are 
available upon request from the Office of Compliance, Center for 
Devices and Radiological Health (HFZ-307), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, or from Food and 
Drug Administration district offices. Subsequent annual registration 
shall be accomplished on Form FDD-2891a (Annual Registration of Device 
Establishment), which will be furnished by FDA to establishments whose 
registration for that year was validated under Sec. 807.35(a). The 
forms will be mailed to the owner or operators of all establishments 
via the official correspondent in accordance with the schedule as 
described in Sec. 807.21(a). The completed form shall be mailed to the 
address designated in this paragraph 30 days after receipt from FDA.
* * * * *
    6. Section 807.40 is revised to read as follows:


Sec. 807.40  Establishment registration and device listing for U.S. 
agents of foreign manufacturers of devices.

    (a) Each foreign device manufacturer who exports devices into the 
United States shall designate a person as their U.S.-designated agent, 
who is responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,
    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications.
    (b) The foreign manufacturer shall provide FDA with a statement of 
authorization for their U.S.-designate to perform MDR reporting duties 
under part 803 of this chapter, and to register, list, and submit 
premarket notifications under this part. The foreign manufacturer must 
provide this statement of authorization along with the name, address, 
and telephone number of the person initially designated, or any 
subsequent person designated as the U.S.-designated agent, within 5 
days of the initial or subsequent designation. Information shall be 
sent to the Center for Devices and Radiological Health, Medical Device 
Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 
20847-3002.
    (c) The U.S.-designated agent of a foreign device manufacturer that 
exports devices into the United States is required to register the 
foreign manufacturer's establishments or places of business, and to 
list the foreign manufacturer's devices, in accordance with subpart B 
of this part, unless exempt under subpart D of this part, and to submit 
premarket notifications in accordance with subpart E of this part. The 
information submitted shall be in the English language.

    Dated: October 25, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-29906 Filed 12-8-95; 8:45 am]
BILLING CODE 4160-01-P